Compass Therapeutics Provides Corporate Update and Announces Advancement of a New Drug Candidate

Rhea-AI Summary

Compass Therapeutics (NASDAQ: CMPX) provided a corporate update highlighting key developments in its oncology pipeline. The company's lead candidate tovecimig (CTX-009) is on track for Phase 2/3 top-line data in biliary tract cancer by Q1 2025. A new drug candidate, CTX-10726, a PD-1 x VEGF-A bispecific antibody, is advancing with IND submission expected by end of 2025.

Two Phase 2 biomarker trials are planned for mid-2025: tovecimig in DLL4-positive colorectal cancer and CTX-471 in NCAM/CD56 expressing tumors. The Phase 1 dose-escalation study of CTX-8371 has fully enrolled its third cohort, with preliminary data expected in H2 2025.

The company reports an estimated $127 million in cash and marketable securities at YE 2024, providing runway into Q1 2027.

Positive

• Strong cash position of $127M providing extended runway into Q1 2027
• Multiple clinical milestones expected in 2025, including Phase 2/3 data readout
• No dose limiting toxicities observed in CTX-8371 Phase 1 trial
• Pipeline expansion with new drug candidate CTX-10726

Negative

• Key clinical data readouts not expected until late 2025/2026
• Multiple clinical programs requiring significant capital investment

Insights

Financial Analyst

The financial outlook for Compass Therapeutics appears solid with $127 million in cash reserves, providing runway into Q1 2027. This substantial cash position significantly de-risks near-term operations and upcoming clinical milestones. The imminent Phase 2/3 tovecimig data readout in Q1 2025 represents a important catalyst that could drive significant value. The company's diversified pipeline, including four distinct clinical programs, provides multiple shots on goal and reduces development risk. The advancement of CTX-10726 demonstrates pipeline expansion capabilities without immediate capital needs. Key value inflection points are well-distributed throughout 2025, including two Phase 2 trial initiations mid-year and CTX-8371 preliminary data in H2.

Oncology Research Analyst

The pipeline developments show strategic positioning in high-value oncology segments. Tovecimig's DLL4 x VEGF-A bispecific mechanism represents an innovative approach in biliary tract cancer, where treatment options are The new CTX-10726 program leverages proven PD-1 and VEGF-A pathways with a novel bispecific design, potentially offering enhanced efficacy over existing monotherapies. The biomarker-driven approach for CTX-471 in NCAM/CD56 expressing tumors and tovecimig in DLL4-positive colorectal cancer demonstrates sophisticated patient selection strategy. The absence of dose-limiting toxicities in CTX-8371's Phase 1 study suggests a favorable safety profile for their PD-1 x PD-L1 bispecific platform.

Market Research Analyst

The company's strategic focus on bispecific antibodies aligns with growing market demand for next-generation immunotherapies. The advancement into biomarker-selected patient populations could lead to higher success rates in clinical trials and stronger market positioning. The diversification across multiple cancer types (biliary tract, colorectal, NCAM-positive tumors) expands market opportunity. The collaboration with MD Anderson Cancer Center adds credibility and could accelerate clinical development. The combination strategy with standard-of-care treatments (paclitaxel, gemcitabine/cisplatin/durvalumab) positions these therapies for potential first-line and second-line treatment options, maximizing commercial potential.

• Top-line Phase 2/3 data readout for CTX-009, now named tovecimig (a DLL4 x VEGF-A bispecific), in patients with biliary tract cancer (BTC) is on track for end of Q1 2025.
• CTX-10726 (a novel PD-1 x VEGF-A bispecific) is advancing as a new drug candidate after a year of preclinical development, with YE 2025 IND expected.
• Two Phase 2 biomarker trials are expected to initiate in mid-2025: tovecimig (in DLL4-positive colorectal cancer) and CTX-471 (in NCAM/CD56 expressing tumors).
• Fully enrolled the third dosing cohort of the Phase 1 dose-escalation study of CTX-8371 (PD-1 x PD-L1 bispecific) with preliminary data expected in the second half of 2025.
• Estimated $127 million in cash and marketable securities at YE 2024, which is expected to provide cash runway into Q1 2027.
  

BOSTON, Jan. 08, 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 a corporate and financial update.

“We are approaching a key catalyst for the company with the top-line data readout at the end of the first quarter for our Phase 2/3 combination study of tovecimig, which is our new nonproprietary name for CTX-009, in patients with advanced BTC,” said Thomas Schuetz, MD, PhD, CEO of Compass and Vice Chairman of the Board of Directors. “In addition, we are very excited to announce our new drug candidate, CTX-10726, a novel PD-1 x VEGF-A bispecific antibody. CTX-10726 builds on our deep VEGF-IO expertise and our research team has been rigorously advancing this candidate for the past year. We expect to submit an IND by year-end with initial proof-of-concept clinical data in 2026.”

“Finally, we are making good progress on designing our two new Phase 2 biomarker studies with tovecimig and CTX-471 and continue to expect initiation of these clinical trials in mid-2025.”

DEVELOPMENT PIPELINE UPDATES:

Tovecimig (CTX-009 - DLL4 x VEGF-A bispecific antibody)

• Top-line data readout in the U.S. on track for the end of Q1 2025 for COMPANION-002, the Company’s Phase 2/3 randomized trial of tovecimig in combination with paclitaxel in patients with advanced BTC (see press release).
• Continuing to design and plan a Phase 2 study in patients with DLL4-positive colorectal cancer in the second-line setting in combination with chemotherapy, which is expected to initiate in mid-2025.
• An IST (investigator sponsored study) of tovecimig in patients with BTC in the first-line setting at The University of Texas MD Anderson Cancer Center is being initiated in Q1 2025. Tovecimig will be added to the standard first-line regimen of gemcitabine, cisplatin, and durvalumab (see press release).
  

CTX-471 (CD137 agonist antibody)

• Phase 2 trial initiation of CTX-471 in patients with tumors expressing neural cell adhesion molecule (NCAM or CD56) is expected in mid-2025.

• Presented CTX-471 clinical data at multiple scientific meetings in 2024, including data demonstrating durable clinical responses in Phase 1 presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and data showing a correlation between levels of NCAM (CD56) expression and disease control presented at the 39th Society for Immunotherapy of Cancer 2024 Annual Meeting.
  

CTX-8371 (PD-1 x PD-L1 bispecific antibody)

• CTX-8371 is a next generation bispecific checkpoint inhibitor that simultaneously targets PD-1 and PD-L1 and exhibits a unique mechanism-of-action that involves cleavage of cell surface PD-1.
• The third dosing cohort in the Phase 1 dose-escalation study of CTX-8371 is fully enrolled; no dose limiting toxicities (DLTs) have been observed to date.

CTX-10726 (PD-1 x VEGF-A bispecific antibody)

• CTX-10726 is a tetravalent PD-1 x VEGF-A bispecific antibody discovered and engineered at Compass. CTX-10726 is designed to synergistically deliver VEGF-A blockade and checkpoint inhibition, potentially applicable to multiple solid tumor indications.
• The bispecific antibody demonstrates a highly stable structure with high affinity target binding. CTX-10726 exhibits more potent PD-1 blockade compared with data reported for other drugs in the class.
• IND-enabling studies have been ongoing, and we expect to submit an IND by the end of 2025.
• Compass’s deep experience in discovery, pre-clinical, and clinical work focused on complementary bispecific approaches that simultaneously target angiogenesis and immuno-oncology uniquely positions us to rapidly progress this candidate to an IND filing and Phase 1 clinical development.

In addition, the Company had an estimated $127 million in cash and marketable securities as of December 31, 2024, which is expected to provide cash runway into Q1 2027.

About Compass Therapeutics
Compass Therapeutics, Inc. is a clinical-stage oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass’s scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. The company pipeline of novel product candidates is designed to target multiple critical biological pathways required for an effective anti-tumor response. These include modulation of the microvasculature via angiogenesis-targeted agents, induction of a potent immune response via activators on effector cells in the tumor microenvironment, and alleviation of immunosuppressive mechanisms used by tumors to evade immune surveillance. Compass plans to advance its product candidates through clinical development as both standalone therapies and in combination with proprietary pipeline antibodies based on supportive clinical and nonclinical data. The company was founded in 2014 and is headquartered in Boston, Massachusetts. For more information, visit the Compass Therapeutics website at https://www.compasstherapeutics.com.

Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Compass’s financial position to continue advancing its product candidates, expectations about cash runway, business and development plans, and statements regarding Compass’s product candidates, including their development and clinical trial milestones such as the expected trial design, timing of enrollment, patient dosing and data readouts, regulatory plans with respect to Compass’s product candidates and the therapeutic potential thereof. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, Compass’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass’s ability to identify additional product candidates for development, Compass’s ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statements are made as of the date of this press release, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the U.S. Securities and Exchange Commission (SEC) available at www.sec.gov, including without limitation Compass’s latest Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC.

Investor Contact
ir@compasstherapeutics.com

Media Contact
Anna Gifford, Chief of Staff
media@compasstherapeutics.com
617-500-8099

FAQ

When will Compass Therapeutics (CMPX) report Phase 2/3 data for tovecimig in biliary tract cancer?

Compass Therapeutics expects to report top-line data from the Phase 2/3 trial of tovecimig in biliary tract cancer by the end of Q1 2025.

What is CMPX's cash runway based on their current financial position?

With $127 million in cash and marketable securities as of December 31, 2024, Compass Therapeutics expects to have sufficient funding into Q1 2027.

When will CMPX submit the IND for their new drug candidate CTX-10726?

Compass Therapeutics expects to submit the IND for CTX-10726, their PD-1 x VEGF-A bispecific antibody, by the end of 2025.

What are the planned Phase 2 trials for CMPX in mid-2025?

Compass plans to initiate two Phase 2 biomarker trials in mid-2025: tovecimig in DLL4-positive colorectal cancer and CTX-471 in NCAM/CD56 expressing tumors.

What is the development status of CMPX's CTX-8371 program?

The third dosing cohort in the Phase 1 dose-escalation study of CTX-8371 is fully enrolled, with no dose limiting toxicities observed and preliminary data expected in the second half of 2025.