Compass Therapeutics(CMPX) - 2024 Q2 - Quarterly Results

Corporate and Pipeline Highlights Compass Therapeutics provides an overview of its Q2 2024 corporate and pipeline achievements Q2 2024 Key Achievements Compass Therapeutics announced significant progress across its clinical pipeline in Q2 2024, including trial completions, new study designs, and a strong cash position - Completed enrollment of 150 patients in the COMPANION-002 Phase 2/3 trial of CTX-009 for biliary tract cancers (BTC), with top-line data anticipated in Q1 2025[1] - Based on encouraging preliminary data from the COMPANION-003 trial, the company is evaluating designs for a new Phase 2 study of CTX-009 combined with chemotherapy for second-line, DLL4-positive colorectal cancer (CRC)[1] - Planning a Phase 2 monotherapy trial for CTX-471 in patients with tumors expressing a newly identified biomarker, while discontinuing the combination study with KEYTRUDA[2] - The Phase 1 dose-escalation study of CTX-8371 completed its first dosing cohort without observing dose-limiting toxicities and has begun enrolling the second cohort[2] - Ended the first quarter with $146 million in cash and marketable securities, which is expected to provide a cash runway into the first quarter of 2027[3] CEO Commentary The CEO emphasizes key clinical trial progress for CTX-009 and positive developments across other pipeline programs - The CEO emphasized the achievement of completing enrollment in the COMPANION-002 Phase 2/3 trial for CTX-009 in patients with Biliary Tract Cancer (BTC)[3] - An Investigator Sponsored Trial at MD Anderson Cancer Center was approved to evaluate CTX-009 in the front-line setting for BTC patients[3] - Encouraging median overall survival data from the CTX-009 monotherapy trial in advanced Colorectal Cancer (CRC) is driving the design of a new study combining CTX-009 with chemotherapy for second-line, DLL4-positive patients[3] Development Pipeline Updates Detailed updates on the progress of Compass Therapeutics' key clinical development programs CTX-009 (DLL4 and VEGF-A bispecific antibody) Enrollment for the Phase 2/3 COMPANION-002 trial in Biliary Tract Cancers (BTC) is complete (n=150), with top-line data expected in Q1 2025. An investigator-sponsored trial for first-line BTC has been approved. Preliminary Phase 2 data in Colorectal Cancer (CRC) showed a 5% Objective Response Rate and 10.2 months median Overall Survival, leading to a new trial design for second-line, DLL4-positive CRC patients instead of continuing the current trial - Completed enrollment (n=150) in the COMPANION-002 Phase 2/3 trial for advanced BTC, with top-line data expected in Q1 2025. The drug has also received FDA Fast Track Designation[4] - An Investigator Sponsored Trial (IST) was approved to evaluate CTX-009 in the first-line BTC setting, added to the standard regimen of gemcitabine, cisplatin, and durvalumab[4] Preliminary Phase 2 Data for CTX-009 Monotherapy in CRC | Metric | Result | | :--- | :--- | | Objective Response Rate (ORR) | 5% (2/41 patients) | | Median Progression-Free Survival (PFS) | 3.9 months | | Disease Control Rate (DCR) | 71% (29/41 patients) | | Median Overall Survival (OS) | 10.2 months | - Based on preliminary results from the COMPANION-003 trial, the company will not proceed to Stage 2 and is instead designing a new Phase 2 study for CTX-009 in combination with chemotherapy for second-line, DLL4-positive CRC patients[5] CTX-471 (CD137 agonist antibody) A potential biomarker for CTX-471 response was identified from a Phase 1b biopsy analysis, prompting the planning of a new Phase 2 monotherapy trial for patients with tumors expressing this biomarker. The combination study with Merck's KEYTRUDA will be discontinued due to an observed suppression of proinflammatory cytokines not seen in monotherapy - The Phase 1b monotherapy study observed five responses in patients who had previously received checkpoint inhibitors, including a complete response in a small cell lung cancer patient and a 27% ORR in advanced melanoma patients[6] - Analysis of biopsy specimens revealed a potential biomarker of response, leading to the planning of a Phase 2 monotherapy study in patients whose tumors express this biomarker[6] - The combination study of CTX-471 with KEYTRUDA (pembrolizumab) will be discontinued due to an unexpected suppression of proinflammatory cytokines[7] CTX-8371 (PD-1 x PD-L1 bispecific antibody) The first-in-human Phase 1 dose-escalation study of CTX-8371, a next-generation bispecific checkpoint inhibitor, is progressing well. The first dosing cohort was completed in June 2024 with no dose-limiting toxicities observed, and enrollment for the second cohort has commenced - The first patient in the Phase 1 study was dosed in April 2024[7] - The first dosing cohort was completed with no dose-limiting toxicities (DLTs) observed, and the second cohort has been initiated[2][7] General Updates The company continues its preclinical and discovery work, exploring synergies between VEGF blockade and CD137 agonism to identify new drug candidates. Additionally, two promotions were made to the executive leadership team - Compass continues to explore synergies observed in pre-clinical work between VEGF blockade and CD137 agonism to identify novel drug candidates[8] - Announced two promotions on the executive leadership team: Jonathan Anderman to SVP, General Counsel & Corporate Secretary, and Bing Gong to SVP, Discovery Research[8] Financial Results and Position An overview of Compass Therapeutics' financial performance and cash position for Q2 2024 Financial Performance (Q2 2024) Compass Therapeutics reports Q2 2024 net loss and license revenue, with increased losses compared to the prior year Net Loss Overview | Period | Net Loss (in millions) | Net Loss Per Share | | :--- | :--- | :--- | | Q2 2024 | $13.1 | $0.10 | | Q2 2023 | $11.3 | $0.09 | | H1 2024 | $23.9 | $0.17 | | H1 2023 | $19.1 | $0.15 | - The company received a $1 million milestone payment related to a Phase 1 trial of CTX-009 in China, which was recognized as $850 thousand of license revenue[9] R&D and G&A Expenses Research and Development and General and Administrative expenses increased in Q2 2024 due to clinical costs and CEO departure-related expenses Q2 2024 Expense Breakdown | Expense Category | Q2 2024 (in millions) | Q2 2023 (in millions) | Change Driver | | :--- | :--- | :--- | :--- | | R&D Expenses | $11.2 | $10.2 | +$2.5M in clinical costs for COMPANION-002, offset by -$1.8M in manufacturing expense | | G&A Expenses | $4.7 | $3.1 | Increase due to expenses related to the departure of the CEO | Cash Position and Runway Compass Therapeutics maintains a strong cash position of $146 million, providing a runway into Q1 2027, despite a slight decrease from year-end 2023 Cash and Marketable Securities | Metric | Amount (in millions) | Date | | :--- | :--- | :--- | | Cash and marketable securities | $146 | June 30, 2024 | | Cash and marketable securities | $152 | Dec 31, 2023 | - The current cash position is expected to provide a runway into the first quarter of 2027[12] - During the first six months of 2024, the company's cash position decreased by $6 million, with cash used in operations being partially offset by $18 million received from stock issuance via its at-the-market (ATM) offering program[12] Company and Product Information Key details about Compass Therapeutics and its lead product candidate, CTX-009 About CTX-009 CTX-009 is a bispecific antibody targeting DLL4 and VEGF-A, demonstrating robust anti-tumor activity across various solid tumors - CTX-009 is a bispecific antibody that blocks both DLL4 and VEGF-A signaling pathways, which are critical to angiogenesis and tumor vascularization[13] - Preclinical and early clinical data suggest robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic, and non-small cell lung cancer[13] About Compass Therapeutics Compass Therapeutics is a clinical-stage biopharmaceutical company focused on developing proprietary antibody-based cancer therapies - Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics[14] - The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth[14] - The pipeline is designed to target multiple biological pathways for an effective anti-tumor response, including modulation of microvasculature and induction of potent immune responses[14]