Question-and-Answer SessionAnd I was looking at your stock price year-to-date, up 290%. I mean that's quite impressive compared to XBI of 30%. So the company is clearly doing something right. Can you tell us -- maybe we start off with the two clinical stage programs. And if you could maybe provide us an overview of both programs, target indications and then we can dig in a little bit more.Thomas SchuetzCEO & Vice Chairman Sure. Yes, I think to your first point, I think it might be related to our high-qualit ...

Summary of Compass Therapeutics Conference Call Company Overview - **Company**: Compass Therapeutics (NasdaqCM:CMPX) - **Location**: Boston - **Industry**: Biotechnology, specifically monoclonal antibody discovery and development in oncology - **Current Pipeline**: Three drugs in clinical trials: - Tovecimig (DLL4 VEGF-A bispecific antibody) - CTX-471 (next generation CD137 agonist antibody) - CTX-8371 (first-in-class bispecific antibody targeting PD-1 and PD-L1) - **Upcoming Drug**: 10726 (novel PD-1 VEGF-A bispecific antibody) entering the clinic soon [4][5][52] Key Points and Arguments Clinical Trials and Drug Efficacy - **Tovecimig**: - Currently in a randomized trial for advanced biliary tract cancer, achieving a statistically significant primary endpoint of overall response rate, tripling the response rate compared to control [6][7] - Secondary endpoints include progression-free survival (PFS) and overall survival (OS), with analyses expected in late Q1 2026 [6][8] - Clinically meaningful hazard ratios for PFS and OS are anticipated to be less than 0.7, with specific assumptions for control and treatment arms [7][8] - **CTX-8371**: - Demonstrated promising results with three confirmed responses in a small cohort, including significant tumor reductions in patients with non-small cell lung cancer and triple-negative breast cancer [41][42] - Cohort expansions planned based on initial positive responses [43] - **10726**: - Preclinical work completed, IND submission planned, with a phase one study to begin early next year targeting multiple cancer types [49][50] Market Potential - **Biliary Tract Cancer**: - Approximately 25,000 new cases diagnosed annually in the U.S., with about 15,000 patients eligible for second-line therapy [30] - Potential market size for second-line therapies estimated at nearly $3 billion annually in the U.S. alone [32] Competitive Landscape - Limited activity in mutation-agnostic approaches for biliary tract cancer, with most recent approvals being mutation-specific [33] - Akeso's frontline BTC program is noted, but results are not expected until early 2030s [33] Regulatory Considerations - Discussions with the FDA suggest that achieving favorable trends in OS alongside positive PFS results could facilitate a productive dialogue regarding approval [25][26] Future Catalysts - Key upcoming events include: - PFS and OS readout for tovecimig in late Q1 2026 - Phase one initiation for 10726 - Cohort expansion for CTX-8371 - Basket study for CTX-471 [52] Additional Important Information - **Crossover in Trials**: Approximately half of the control arm patients crossed over to the active arm, which necessitated the use of statistical methods to adjust for this in analyses [12][13] - **Market Research**: Comprehensive third-party market research conducted to understand treatment regimens and patient demographics [27][30] - **Pricing Strategy**: Recent oncology drug launches priced around $36,000 to $40,000 per month, with conservative estimates suggesting a potential annual cost of $200,000 per patient [31][32] This summary encapsulates the critical insights from the conference call, highlighting the company's pipeline, market potential, competitive landscape, and future catalysts.

Core Viewpoint - Compass Therapeutics Inc. (NASDAQ:CMPX) is viewed positively by analysts due to significant advancements in its clinical pipeline, with price targets set at $12 and $24 by different analysts [1][2]. Company Developments - The company has made notable progress in its drug pipeline, particularly with the development of CTX-10726, a tetravalent antibody aimed at inhibiting tumor angiogenesis [2]. - During the third-quarter 2025 results, the CEO highlighted lower mortality rates in a randomized trial of tovecimig for patients with advanced biliary tract cancer (BTC) and anticipates delivering overall survival (OS) and progression-free survival (PFS) data in the first quarter of the next year [3]. - The company expects to support its first Biologics License Application (BLA) filing in the second half of 2026, based on secondary endpoint data that builds on previously reported primary endpoint results [4]. Market Potential - Recent market research indicates approximately 25,000 new BTC diagnoses annually in the United States, suggesting a significant market opportunity for tovecimig, especially for patients lacking approved therapeutic options [4]. Financial Performance - The company reported a net loss of $14.3 million, or $0.08 per share, which is an increase from a net loss of $10.5 million in the same quarter the previous year. This wider loss is attributed to increased research and development expenses, which rose to $12.8 million from $8.6 million year-over-year [5]. Company Overview - Compass Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing proprietary antibody-based therapies for cancer, emphasizing the interplay between angiogenesis, the immune system, and tumor growth [6].

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]

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]

Company Overview - Compass Therapeutics is a monoclonal antibody development and discovery company located in Boston, Massachusetts [2] - The company has three drugs currently in clinical trials, which include two bispecific antibodies and one monoclonal antibody [2] - A fourth drug is expected to have an Investigational New Drug (IND) application filed in the next quarter [2] Lead Program - The lead program of Compass Therapeutics is a DLL4 VEGF-A bispecific antibody named tovecimig [2] - Recent announcements regarding the lead program were made earlier this year [2]

Company Overview - Compass Therapeutics is a monoclonal antibody development and discovery company located in Boston, Massachusetts [2] - The company has three drugs currently in clinical trials, which include two bispecific antibodies and one monoclonal antibody [2] - A fourth drug is expected to have an Investigational New Drug (IND) application filed in the next quarter [2] Lead Program - The lead program of Compass Therapeutics is a DLL4 VEGF-A bispecific antibody named tovecimig [2] - Recent announcements regarding the development of tovecimig were made earlier this year [2]

Core Viewpoint - Compass Therapeutics, Inc. reported its second quarter 2025 financial results and provided updates on its clinical and pre-clinical programs, highlighting progress in its oncology-focused pipeline and a strong cash position to support operations into 2027 [1][11][17]. Financial Performance - The net loss for Q2 2025 was $19.9 million, or $0.14 per share, compared to a net loss of $13.1 million, or $0.10 per share, for the same period in 2024, marking an increase in loss of approximately 51% [11][22]. - For the first six months of 2025, the net loss was $36.5 million, or $0.26 per share, compared to $23.9 million, or $0.17 per share, for the same period in 2024, reflecting a 53% increase in loss [11][22]. - As of June 30, 2025, the company had $101 million in cash and marketable securities, down from $127 million at the end of 2024, providing a cash runway into 2027 [17][24]. Clinical Development Updates - The Phase 2/3 trial of tovecimig met its primary endpoint, showing fewer deaths than initially projected, which may indicate a positive impact on overall survival [2][5][6]. - In the Phase 1 study of CTX-8371, two confirmed partial responses were observed, including a complete resolution of target lesions in a non-small cell lung cancer patient and over 90% reduction in a triple-negative breast cancer patient [3][5]. - CTX-10726 is on track for IND submission in Q4 2025, with initial preclinical data suggesting it may outperform ivonescimab in PD-1 inhibition and anti-tumor activity [3][12]. Research and Development Expenses - R&D expenses for Q2 2025 were $16.4 million, an increase of 47% from $11.2 million in Q2 2024, primarily due to additional manufacturing costs related to tovecimig and CTX-10726 [13]. - For the first half of 2025, R&D expenses totaled $29.5 million, up 42% from $20.7 million in the same period in 2024 [13]. General and Administrative Expenses - G&A expenses for Q2 2025 were $4.7 million, consistent with Q2 2024, while for the first half of 2025, G&A expenses increased by 20% to $9.6 million compared to $8.0 million in the same period in 2024, attributed to higher share-based compensation [14].

Company Overview - Compass Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on oncology, developing proprietary antibody-based therapeutics to treat various human diseases [3] - The company emphasizes the relationship between angiogenesis, the immune system, and tumor growth, aiming to create a robust pipeline of novel product candidates [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] Upcoming Financial Results and Updates - Compass Therapeutics will release its financial results for the quarter ended June 30, 2025, and provide updates on the ongoing tovecimig Phase 2/3 study, clinical data for CTX-8371, and preclinical data for CTX-10726 on August 11, 2025, at 8:00 AM ET [1] - A webcast and conference call will be held to discuss these updates, with a replay available for 90 days on the company's Events page [2]

Core Insights - Compass Therapeutics reported positive progress in its clinical trials, particularly achieving the primary endpoint in the COMPANION-002 trial for tovecimig in biliary tract cancer (BTC) [2][4][5] - The company has a strong financial position with $113 million in cash and marketable securities, providing a cash runway into 2027 [2][13] Clinical Development Updates - Tovecimig (DLL4 x VEGF-A bispecific antibody) achieved a 17.1% overall response rate (ORR) in the COMPANION-002 trial, significantly higher than the 5.3% ORR for paclitaxel alone [4][5] - The first patient has been dosed in an Investigator Sponsored Trial (IST) at The University of Texas MD Anderson Cancer Center for tovecimig in the first-line setting for BTC [2][4] - CTX-10726, a PD-1 x VEGF-A bispecific antibody, is on track for an IND filing expected in Q4 2025, with clinical data anticipated in 2026 [2][10] - CTX-8371, a PD-1 x PD-L1 bispecific antibody, has progressed to the fourth dosing cohort in a Phase 1 study, with data expected in the second half of 2025 [2][10] Financial Performance - The net loss for Q1 2025 was $16.6 million, or $0.12 per share, compared to a net loss of $10.8 million, or $0.08 per share, in Q1 2024 [9][18] - Research and Development (R&D) expenses increased by 37% to $13.1 million in Q1 2025, primarily due to additional spending on clinical trials [10][18] - General and Administrative (G&A) expenses rose by 51% to $4.9 million, largely due to increased personnel costs [12][18] Cash Position - As of March 31, 2025, the company had $113 million in cash and marketable securities, down from $127 million at the end of 2024, indicating a cash runway into 2027 [13][20]