Question-and-Answer SessionThomas SchuetzCEO & Vice Chairman Sure. Compass, we're based in Boston. We're a monoclonal antibody discovery and development company in oncology. We currently have 3 drugs in the clinic and a fourth drug about to enter the clinic. So 2026, to answer your question specifically, is going to be an incredibly eventful year for us. We -- for our lead program, Tovecimig, a DLL4xVEGF-A bispecific antibody. We have a readout on the secondary endpoints of progression-free survival and ove ...

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].

Tovecimig Clinical Trial Results (COMPANION-002 Study) - The COMPANION-002 study is a Phase 2/3 registrational-intent study in patients with BTC who have received one prior line of therapy[9] - In the Intent-to-Treat population, the Overall Response Rate (ORR) for Tovecimig + Paclitaxel was 17.1% (19 out of 111 patients) compared to 5.3% (3 out of 57 patients) for Paclitaxel alone, with a two-sided p-value of 0.031[12] - The Complete Response (CR) rate in the Tovecimig + Paclitaxel arm was 0.9% (1 out of 111 patients), while the Partial Response (PR) rate was 16.2% (18 out of 111 patients)[12] - Stable Disease (SD) was observed in 44.1% of patients (49 out of 111) in the Tovecimig + Paclitaxel arm compared to 33.3% (19 out of 57) in the Paclitaxel arm[12] - Progressive Disease (PD) was observed in 16.2% of patients (18 out of 111) in the Tovecimig + Paclitaxel arm compared to 42.1% (24 out of 57) in the Paclitaxel arm[12] Tovecimig Development and Potential - Tovecimig is a bispecific antibody targeting DLL4 and VEGF-A, designed to disrupt tumor vessel formation and angiogenesis[6, 7] - The company anticipates top-line Phase 2/3 data for PFS, OS, and DoR in Q4 2025[25] - Tovecimig has the potential to become a standard of care in 2L BTC, with PFS, OS and DoR data expected in Q4 2025[18] Market and Unmet Needs - There are significant unmet needs in current treatments for BTC, with approximately 85% of 2L patients having limited treatment options[19, 20] - Incidence of BTC is significant, with an estimated ~23,000 cases annually[22] - Projected ~100,000 incidence of liver and intrahepatic bile duct cancer by 2040[23]

Core Insights - The article expresses cautious optimism regarding Compass Therapeutics (NASDAQ: CMPX) and highlights the importance of an upcoming readout that is expected to occur early in the year [1]. Company Analysis - Compass Therapeutics is under scrutiny for its clinical trials and the potential implications of the results on its stock performance [1]. - The author has a background in biochemistry and extensive experience in analyzing biotech companies, which adds credibility to the insights shared about Compass Therapeutics [1]. Industry Context - The article emphasizes the significance of understanding the science behind biotech investments, suggesting that investors should conduct thorough due diligence to avoid pitfalls in this sector [1].

Core Insights - Compass Therapeutics presented promising preclinical data on CTX-471, a CD137 agonist antibody, at the AACR Annual Meeting, indicating enhanced efficacy in models of immune checkpoint failure through simultaneous blockade of neo-angiogenesis [1][2][3] Company Overview - Compass Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing proprietary antibody-based therapeutics for oncology, with a scientific emphasis on the interplay between angiogenesis, the immune system, and tumor growth [10] Product Development - CTX-471 is currently in a Phase 1b clinical trial for patients with solid tumors that have progressed after at least three months on approved PD-1 or PD-L1 inhibitors, showing partial responses in melanoma, small cell lung cancer, and mesothelioma [5][6] - The combination of CTX-471 with tovecimig, an investigational bispecific antibody targeting DLL4 and VEGF-A, demonstrated significant anti-tumor activity in resistant murine models, suggesting potential clinical benefits for patients who have failed checkpoint inhibitors [6][9] Mechanism of Action - The combination therapy of CTX-471 and tovecimig enhances innate and adaptive anti-tumor immunity, leading to increased tumor cell killing and improved interferon signaling, which may provide therapeutic advantages in previously resistant cancer types [3][6] Clinical Trials - Tovecimig is being evaluated in the ongoing Phase 2/3 trial (COMPANION-002) in combination with paclitaxel for patients with advanced metastatic or recurrent biliary tract cancers, showing promise in heavily pre-treated patients resistant to anti-VEGF therapies [9]