Financial Performance - As of June 30, 2024, the company reported net losses of 11.3 million for the same period in 2023, and 19.1 million in 2023[58]. - The net loss for the three months ended June 30, 2024, was 11.3 million for the same period in 2023, reflecting an increase of 24.6 million, compared to 850 thousand, a significant increase from 1 million milestone payment from Elpiscience[70]. - For the six months ended June 30, 2024, licensing revenue was 1.0 million, or 9%, for the three months ended June 30, 2024, totaling 10.2 million in the same period in 2023[71]. - Research and development expenses for the six months ended June 30, 2024, increased by 20.7 million compared to 1.6 million, or 52%, for the three months ended June 30, 2024, reaching 3.1 million in the same period in 2023[72]. - General and administrative expenses for the six months ended June 30, 2024, increased by 8.0 million compared to 146 million in cash, cash equivalents, and marketable securities, expected to fund operations into Q1 2027[59]. - The company has sufficient cash, cash equivalents, and marketable securities to fund operations and capital expenditures into Q1 2027, based on current plans[89]. - The company expects future funding requirements to increase substantially due to ongoing activities, including clinical trials and regulatory approvals[88]. - The company expects to require additional funding for the clinical development of three programs: CTX-009, CTX-471, and CTX-8371[89]. - The company plans to finance cash needs through equity and debt financings, collaborations, and licensing arrangements, which may dilute ownership interest[90]. Clinical Trials and Development - CTX-009 is currently in two ongoing U.S. clinical trials, with a Phase 2 trial for metastatic colorectal cancer showing a disease control rate of 71% and an overall response rate of 5%[48][49]. - A randomized Phase 2/3 trial for CTX-009 in combination with paclitaxel for biliary tract cancer has fully enrolled 150 patients, with top-line data expected in Q1 2025[49]. - The FDA granted Fast Track Designation to CTX-009 in combination with paclitaxel for the treatment of metastatic or locally advanced biliary tract cancer in April 2024[50]. - CTX-471, a monoclonal antibody, is currently in a Phase 1b clinical trial, with plans for a Phase 2 monotherapy study based on a newly identified biomarker[55][52]. - CTX-8371, a bispecific antibody targeting PD-1 and PD-L1, has completed its first cohort in a clinical trial with no dose-limiting toxicities observed[56]. - The company expects to continue incurring significant expenses for clinical development and regulatory approval for the next several years[58]. - If regulatory approval is received for CTX-009, CTX-471, or CTX-8371, significant commercialization expenses will be incurred related to manufacturing, sales, marketing, and distribution[89]. Legal and Compliance - There were no changes in internal control over financial reporting during the quarter ended June 30, 2024, that materially affected internal controls[93]. - As of the date of the report, the company is not involved in any material legal proceedings, although it may face various claims in the ordinary course of business[95].
Compass Therapeutics(CMPX) - 2024 Q2 - Quarterly Report