Compass Therapeutics Q1 2024 Financial Results and Corporate Update

Compass Therapeutics, Inc., a clinical-stage biopharmaceutical company focusing on oncology, has announced its financial results for the first quarter of 2024 and provided an update on its business activities. The company reported significant progress in its clinical programs, notably receiving FDA Fast Track Designation for CTX-009 in combination with paclitaxel for treating patients with metastatic or locally advanced biliary tract tumors (BTC). Enrollment in the COMPANION-002 Phase 2/3 study for CTX-009 in BTC is on track, with completion expected by mid-2024 and top-line data anticipated in the first quarter of 2025.

The company completed the Stage 1 enrollment for the COMPANION-003 Phase 2 study of CTX-009 in advanced colorectal cancer (CRC) and expects to report top-line data by mid-2024. Further, the Phase 1b study of CTX-471 in combination with KEYTRUDA® for non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and melanoma is progressing. Compass has also initiated a first-in-human clinical study for CTX-8371, a PD-1 x PD-L1 bispecific antibody, and dosed the first patient in April 2024.

In addition, planning for a Phase 2 monotherapy study of CTX-471 in advanced melanoma patients, whose tumors express a newly identified biomarker, is underway. The company's financial stability is reflected by ending the first quarter with $156 million in cash and marketable securities, providing a cash runway into late 2026.

Vered Bisker-Leib, PhD, Chief Executive Officer of Compass Therapeutics, emphasized the significant advances in their clinical programs, particularly CTX-009, which addresses a critical unmet need in BTC treatment with currently low response rates. Thomas Schuetz, MD, PhD, President of R&D and Vice Chair of the Compass Board, highlighted upcoming milestones, including top-line data from COMPANION-002 and COMPANION-003, and the initiation of COMPANION-004 for a new indication of CTX-009.

In the development pipeline, CTX-009 (DLL4 and VEGF-A bispecific antibody) is a key focus. The COMPANION-002 study is a randomized U.S. Phase 2/3 trial evaluating CTX-009 with paclitaxel in advanced BTC patients. The study's primary endpoint is the overall response rate, with secondary endpoints such as progression-free survival and overall survival. Enrollment is set to complete by mid-2024, with top-line data expected early 2025.

CTX-471 (CD137 agonist antibody) is another critical asset. It binds to a unique epitope of the co-stimulatory molecule 4-1BB with optimized affinity. In the Phase 1b monotherapy study, several responses were observed, including a complete response in a small cell lung cancer patient and a 27% objective response rate among advanced melanoma patients. A Phase 2 monotherapy study targeting a newly identified biomarker in melanoma patients is being planned. Concurrently, enrollment continues for a Phase 1b dose-expansion cohort combining CTX-471 with KEYTRUDA® for various cancers.

For CTX-8371 (PD-1 x PD-L1 bispecific antibody), the first patient was dosed in April 2024 in a first-in-human study, with further patient dosing and additional clinical sites currently in progress.

Financially, Compass reported a net loss of $10.8 million for the first quarter of 2024, compared to $7.8 million in the same period in 2023. R&D expenses increased to $9.5 million due to clinical costs associated with CTX-009, while G&A expenses remained relatively stable. The company's cash position improved, ending with $156.3 million in cash and marketable securities as of March 31, 2024.

Compass Therapeutics, founded in 2014 and headquartered in Boston, Massachusetts, focuses on developing antibody-based therapeutics to treat various diseases, particularly targeting angiogenesis, the immune system, and tumor growth. The company's pipeline aims to advance product candidates through clinical development, both as standalone therapies and in combination with other pipeline antibodies.