Compass Therapeutics, Inc. (CMPX) is a clinical-stage, oncology-focused biopharmaceutical company that is at the forefront of developing innovative antibody-based therapeutics to treat a wide range of human diseases. With a strong emphasis on the interplay between angiogenesis and the immune system, Compass Therapeutics is pioneering novel approaches to tackle some of the most formidable challenges in the oncology landscape.
Company Overview
Founded in 2014 and headquartered in Boston, Massachusetts, Compass Therapeutics has quickly established itself as a force to be reckoned with in the biopharmaceutical industry. The company's scientific focus on the intricate relationship between angiogenesis, the immune system, and tumor growth has enabled it to develop a robust pipeline of promising product candidates that leverage its deep understanding of the tumor microenvironment.
Key Assets
At the heart of Compass Therapeutics' portfolio are three key assets: CTX-9 (formerly known as CTX-900), CTX-471, and CTX-8371. CTX-9 is a bispecific antibody that simultaneously targets DLL4 and VEGF-A, two critical pathways involved in angiogenesis and tumor vascularization. Currently undergoing clinical trials as a monotherapy and in combination with chemotherapy, CTX-9 has demonstrated promising results in various solid tumor indications, including colorectal, gastric, cholangiocarcinoma, pancreatic, and non-small cell lung cancer.
Compass is currently conducting two ongoing clinical trials with CTX-9 - a Phase 2 trial as monotherapy in patients with metastatic colorectal cancer who received two or three prior treatment regimens, and a randomized Phase 2/3 trial in combination with paclitaxel in patients with biliary tract cancer who received one prior treatment regimen. Preliminary data from the Phase 2 monotherapy trial showed an overall response rate of 5%, disease control rate of 71%, median progression free survival of 3.9 months, and median overall survival of 10.2 months. Based on these results, Compass is evaluating a second-line trial in metastatic colorectal cancer combined with chemotherapy rather than enrolling the second stage of the Phase 2 monotherapy trial.
CTX-471, on the other hand, is a fully human, IgG4 monoclonal antibody that acts as an agonist of CD137, a key co-stimulatory receptor on immune cells. Preclinical studies have shown that CTX-471 can extensively reprogram the tumor microenvironment, leading to increased recruitment of immune cells, reversion of exhausted cytotoxic CD8 T-cells, and reduction of immunosuppressive regulatory T-cells and tumor-associated macrophages. However, the company faced a setback in 2021 when it encountered an unexpected suppression of pro-inflammatory cytokines during a clinical trial evaluating CTX-471 in combination with KEYTRUDA (pembrolizumab). As a result, the combination study was discontinued, and the company had to re-evaluate its development plans for CTX-471. Compass is now planning a Phase 2 monotherapy study of CTX-471 in patients with tumors that express a newly identified biomarker.
The third asset, CTX-8371, is a bispecific antibody that simultaneously targets PD-1 and PD-L1, the well-known checkpoint inhibitor targets. Preclinical data has demonstrated that CTX-8371 can outperform individual PD-1 and PD-L1 inhibitors, as well as their combination, in activating T-cells and controlling tumor growth in mouse models. In 2022, the company received clearance from the FDA to initiate a Phase 1 clinical trial for CTX-8371, marking an important milestone as it added a new, differentiated asset to the company's pipeline. An IND was accepted and cleared by the FDA in October 2023, and the first patient was dosed in April 2024. The first cohort of this trial was completed in June 2024 with no dose limiting toxicities observed, and Compass initiated the second cohort in July 2024.
Strategic Collaborations
Compass Therapeutics' commitment to innovation is further evident in its strategic collaborations and partnerships. In November 2018, the company entered into an exclusive global licensing agreement with ABL Bio, a South Korean biotechnology company, for the development of CTX-9. This marked a significant milestone for the company as it expanded its pipeline with a promising clinical-stage asset. The company also has a collaboration with Elpiscience Biopharmaceuticals Co., Limited for the development of CTX-9 in Mainland China, Hong Kong, Taiwan, and Macau.
Financials
Financially, Compass Therapeutics has a strong balance sheet, with $146 million in cash, cash equivalents, and marketable securities as of June 30, 2024. This robust cash position is expected to fund the company's operations and capital expenditure requirements into the first quarter of 2027, based on its current plans. Throughout its history, Compass Therapeutics has relied on the proceeds from the sale of its equity securities to fund its operations. The company has raised over $430 million in gross proceeds from equity financings since its inception, including a $76 million capital raise in 2022 and an $18 million equity offering in the first half of 2024.
The company's financial performance has been characterized by consistent investment in research and development, which has accounted for the majority of its operating expenses. In the six months ended June 30, 2024, Compass Therapeutics reported a net loss of $23.9 million, with research and development expenses of $20.7 million and general and administrative expenses of $8.0 million.
For the most recent fiscal year (2023), Compass Therapeutics reported no revenue, a net loss of $42,494,000, operating cash flow of -$40,618,000, and free cash flow of -$40,648,000. In the most recent quarter (Q2 2024), the company reported no revenue, a net loss of $10,787,000, operating cash flow of -$13,888,000, and free cash flow of -$13,888,000. The increase in net loss, operating cash flow, and free cash flow was primarily attributable to higher research and development expenses related to the COMPANION-2 trial for CTX-900 and accrual of expenses associated with the previously announced CEO transition.
Compass Therapeutics reported licensing revenue of $850,000 for the three and six months ended June 30, 2024, which consisted of a milestone payment from its licensee Elpiscience related to the completion of a Phase 1 trial for CTX-9 in China. Research and development expenses increased by 9% and 23% for the three and six month periods, respectively, driven primarily by increased clinical costs for the CTX-9 COMPANION-2 trial. General and administrative expenses also increased by 52% and 29% over the same periods, largely due to costs associated with the company's CEO transition.
As a small-cap company, Compass Therapeutics appears to only operate in the United States and does not disclose performance by geographic markets.
Liquidity
Despite the challenges posed by the ongoing COVID-19 pandemic, Compass Therapeutics has remained resilient, adapting its operations to ensure the continuity of its clinical trials and research activities. The company has also navigated the evolving regulatory landscape, securing key regulatory designations such as the FDA's Fast Track Designation for CTX-9 in combination with paclitaxel for the treatment of patients with metastatic or locally advanced biliary tract cancer.
As of June 30, 2024, Compass Therapeutics had $19.4 million in cash and cash equivalents and $126.82 million in marketable securities. The company's financial position is strong, with a debt-to-equity ratio of 0.00899656182350694, a current ratio of 40.74, and a quick ratio of 40.74. The company has no outstanding credit facilities or credit lines disclosed.
Future Outlook
Looking ahead, Compass Therapeutics is poised to continue its momentum. The company is actively exploring the potential of CTX-9 in additional indications, based on data from preclinical models, biomarker analyses, and clinical data from ongoing trials. Additionally, the company is developing a plan to study the combination of CTX-9 with its novel bispecific checkpoint blocker, CTX-8371, as well as with other checkpoint inhibitors.
The future of Compass Therapeutics is undoubtedly bright, as the company continues to push the boundaries of innovation in the oncology space. With a robust pipeline, strategic partnerships, and a strong financial foundation, Compass Therapeutics is well-positioned to make a significant impact in the fight against cancer and other human diseases. Despite the challenges it has faced, including the departure of CEO Vered Bisker-Leib in May 2024, the company has remained dedicated to developing innovative treatments that have the potential to improve the lives of patients with cancer and other serious diseases.