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]

Summary of Compass Therapeutics FY Conference Call Company Overview - **Company**: Compass Therapeutics - **Ticker**: NasdaqCM:CMPX - **Location**: Boston, Massachusetts - **Industry**: Monoclonal antibody development and discovery in oncology - **Pipeline**: Three drugs in clinical trials (two bispecific antibodies and one monoclonal antibody), with a fourth drug expected to file an IND in the next quarter [2][3] Key Pipeline Developments - **Tavecimab**: - Lead program, a DLL4-VEGF8 bispecific antibody - Achieved primary endpoint of overall response rate in a randomized trial - Notable results: 17.1% response rate in combination arm vs. 5.3% in control arm, statistically significant with a p-value of 0.031 [10][11] - Ongoing randomized trial of Tavecimab plus paclitaxel vs. paclitaxel alone in advanced biliary tract cancer [8] - Significant unmet medical need in biliary tract cancer, with no labeled second-line standard of care [9] - Expected data analysis for progression-free survival (PFS) and overall survival (OS) in Q1 2026 [10][12] - **Monoclonal Antibody 471**: - Next-generation CD137 agonist antibody - Presented data showing responses in difficult-to-treat patient populations, including melanoma and small cell lung cancer [3][4] - **PD1-PDL1 Bispecific Antibody (H371)**: - Early phase I study showing deep responses in patients with non-small cell lung cancer and triple-negative breast cancer [24][25] - Mechanism of action involves dual ligand and receptor blockade, significantly more potent than single agents [22] - **PD1-VEGF8 Bispecific Antibody (10726)**: - Expected IND filing in Q4 2025, with potential clinical data in 2026 [31] - Preclinical studies suggest it may outperform established therapies like Ivernizumab [30] Financial and Operational Highlights - **Recent Financing**: - Completed a $138 million upsized financing, extending cash runway into 2028 [36][37] - Funds will support multiple upcoming milestones, including data readouts and clinical trials for Tavecimab, H371, and 10726 [37] - **Manufacturing Capabilities**: - Developed bispecific manufacturing expertise, achieving commercial-ready yields [32][33] - Yields for bispecific antibodies are significantly higher than traditional monoclonal antibodies [33] Market Opportunity - **Biliary Tract Cancer**: - Approximately 25,000 new cases annually in the U.S., with a significant unmet need for second-line therapies [9][17] - Tavecimab positioned to become the second-line standard of care [9] - **Potential Expansion**: - Plans for a phase II basket study of Tavecimab in various DLL4-positive cancers, including colorectal and ovarian cancers [18][19] Investor Sentiment - **Key Points of Interest**: - Investors are particularly focused on the progress of Tavecimab and the unexpected positive outcomes from H371 [38] - The company is perceived as undervalued based on Tavecimab alone, with potential for increased valuation following positive data readouts [38] Conclusion - Compass Therapeutics is advancing a robust pipeline of innovative therapies targeting significant unmet needs in oncology, with promising early data and a strong financial position to support ongoing development and potential market entry.

Compass Therapeutics (NasdaqCM:CMPX) FY Conference September 08, 2025 11:00 AM ET Company ParticipantsSara Nik - VP & Equity Research - BiotechThomas Schuetz - Co-Founder, Director & CEOSara NikOkay, good morning everyone, and welcome to our next session. I'll be your moderator, Sarah Nick, an Equity Research VP at H. C. Wainwright. And it's my pleasure to introduce our next presenter, Thomas Schutz, CEO of Compass Therapeutics, a clinical stage oncology focused pharmaceutical biopharmaceutical company focu ...

Summary of Compass Therapeutics Conference Call Company Overview - **Company**: Compass Therapeutics (CMPX) - **Industry**: Biotechnology, specifically focused on monoclonal antibody discovery and development in oncology [2][3] Key Achievements and Milestones - **Current Pipeline**: Three drugs in clinical trials with a fourth IND submission expected later in 2025 [3] - **Lead Program**: Tivesamig, a DLL4 VEGF A bispecific antibody, has met primary endpoints in a randomized study for advanced biliary tract cancer [3] - **Survival Data**: Recent updates indicate fewer deaths than projected in the study, with overall survival (OS) and progression-free survival (PFS) data expected in Q1 2026 [3][17] - **Efficacy Signals**: Phase I study of PD-1 PD-L1 bispecific antibody (8,371) shows deep responses in patients with non-small cell lung cancer and triple-negative breast cancer [4] Regulatory and Approval Path - **Regulatory Benchmarks**: No specific benchmarks from the FDA; however, a hazard ratio of 0.6 is targeted for significant treatment effect [9][10] - **Approval Strategy**: Plans to seek full approval based on PFS and OS data, with no discussions for accelerated approval [11][12] - **Control Arm**: Paclitaxel was chosen as the control arm based on FDA guidance, as there is no standard of care for the patient population [18] Safety Profile - **Adverse Events**: Common adverse event is hypertension, similar to Avastin; independent data safety monitoring committee has not identified new safety signals [19][20] Commercial Opportunity - **Market Size**: Estimated 15,000 new patients annually in the U.S. for second-line biliary tract cancer, with a potential market exceeding $3 billion annually [25] - **Commercial Strategy**: Plans to commercialize the drug independently in the U.S. with a targeted sales force of around 50 people [28] Manufacturing and Readiness - **Manufacturing Yields**: Achieved fivefold higher production yields compared to traditional monoclonal antibodies, with cost of goods comparable to small molecules [30][31] Future Outlook - **2026 Goals**: Successful readout from the randomized trial of Tivesamig, FDA interaction, and potential license application; further development of PD-1 PD-L1 bispecific antibody and next-generation bispecific antibody [47][48] Competitive Landscape - **Market Dynamics**: Despite competition in the PD-1/PD-L1 space, there is room for better drugs, and the company aims to define niche indications for its products [36][39] Conclusion - **Financial Position**: Compass Therapeutics has a strong cash position of approximately $230 million, providing a runway into 2028 to support ongoing and future clinical programs [48]

Company Overview - Compass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases [4] - The company focuses on the relationship between angiogenesis, the immune system, and tumor growth, aiming to create a robust pipeline of novel product candidates [4] - Founded in 2014 and headquartered in Boston, Massachusetts, Compass Therapeutics plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies [4] Upcoming Investor Events - Compass Therapeutics will participate in several investor events in September 2025, including: - Citi's 2025 Biopharma Back to School Conference on September 2, 2025, in Boston, MA [2] - Cantor Global Healthcare Conference on September 3, 2025, in New York, NY, at 2:10 PM ET [2] - H.C. Wainwright 27 Annual Global Investment Conference on September 8, 2025, in New York, NY, at 11 AM ET [2] - Morgan Stanley 23 Annual Global Healthcare Conference on September 9, 2025, in New York, NY, at 5:35 PM ET [3] - Webcast links for the Cantor and H.C. Wainwright conferences are provided for investor access [2][3]

Group 1 - Compass Therapeutics, Inc. announced a public offering of 33,290,000 shares of common stock priced at $3.00 per share, along with pre-funded warrants for 6,710,000 shares priced at $2.9999 each, expecting gross proceeds of approximately $120 million [1][2] - The offering is expected to close on or about August 14, 2025, subject to customary closing conditions, with underwriters granted a 30-day option to purchase an additional 6,000,000 shares [1][2] - The net proceeds will be used for commercial readiness preparations, funding research and clinical development of product candidates, and general corporate purposes [2] Group 2 - Jefferies, Piper Sandler, and Guggenheim Securities are acting as joint active bookrunning managers for the offering, with additional firms serving as lead and co-managers [3] - A shelf registration statement for the securities was filed with the SEC on August 30, 2024, and declared effective on September 6, 2024, with a preliminary prospectus supplement already filed [4] Group 3 - Compass Therapeutics is a clinical-stage biopharmaceutical company focused on oncology, developing proprietary antibody-based therapeutics targeting multiple diseases [6] - The company’s scientific focus includes the relationship between angiogenesis, the immune system, and tumor growth, with a robust pipeline of product candidates designed to target critical biological pathways for effective anti-tumor responses [6]

Core Viewpoint - Compass Therapeutics, Inc. has announced a public offering of its common stock and pre-funded warrants to raise capital for commercial readiness, research, and clinical development of its product candidates [1][2]. Group 1: Offering Details - The public offering includes common stock and pre-funded warrants, with all shares being offered by Compass [1]. - Compass plans to grant underwriters a 30-day option to purchase additional shares under the same terms [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for initial preparations for commercial readiness, funding research and clinical development of product candidates, and general corporate purposes [2]. Group 3: Company Overview - Compass Therapeutics is a clinical-stage biopharmaceutical company focused on oncology, developing proprietary antibody-based therapeutics for multiple diseases [5]. - The company’s scientific focus includes the relationship between angiogenesis, the immune system, and tumor growth, with a robust pipeline targeting critical biological pathways for effective anti-tumor responses [5]. - Founded in 2014 and headquartered in Boston, Massachusetts, Compass aims to advance its product candidates through clinical development as standalone therapies and in combination with other proprietary antibodies [5].

Financial Data and Key Metrics Changes - The company ended Q2 2025 with $101 million in cash, providing a runway into 2027 for executing on various programs [34] - The overall response rate for the lead program, Tivesimig, was reported at 17.1%, significantly higher than the control arm [9][10] Business Line Data and Key Metrics Changes - Tivesimig showed a tripling of the overall response rate compared to the control arm, with a p-value of 0.031 [9] - CTX-8371, the PD-1/PD-L1 bispecific antibody, reported two deep partial responses in early cohorts, indicating promising early efficacy [6][19] Market Data and Key Metrics Changes - The ongoing randomized trial for Tivesimig in patients with advanced biliary tract cancer has fewer total deaths than projected, suggesting better-than-expected survival outcomes [11][12] - The company plans to initiate cohort expansions for CTX-8371 in non-small cell lung cancer and triple-negative breast cancer later this year [33] Company Strategy and Development Direction - The company aims to file a license application for Tivesimig in 2026, following a robust interaction with the FDA [31][106] - Future studies will explore indications where both VEGF targeting and PD-1 targeting have shown effectiveness, such as renal cell and gastric cancer [79] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of Tivesimig to extend overall survival in patients, despite the current lower-than-expected mortality rate [40][14] - The company is focused on advancing its pipeline, with multiple milestones expected over the next six quarters [30][31] Other Important Information - The company has fast track designation for Tivesimig, which may lead to priority review upon filing [31] - Preclinical data for CTX-10,726 showed superior tumor control compared to leading drug candidates in its class [27][29] Q&A Session Summary Question: Is there a chance that decreased deaths in the study reflect performance due to drug crossover? - Management confirmed that about half of the patients in the control arm crossed over after progression, and statistical methods will adjust for this in the overall survival analysis [39][40] Question: Can you clarify the timeline for PFS analysis? - Management indicated that the 80% event threshold will not be reached until Q1 2026, and they expect to present a priority dataset at that time [48][50] Question: What is the status of the BLA submission process? - The company is on track with its CMC process and does not foresee it being a limiting factor for BLA submission [55] Question: How confident is the company in the demographics of the study? - Management stated that randomization was stratified by key prognostic variables, which should balance demographics across treatment arms [73] Question: What are the plans for the dose expansion cohorts for CTX-8371? - The company plans a small randomized study of approximately 50 patients to explore different doses in the expansion cohorts [102]