Business Overview and History
Compass Therapeutics, Inc. (CMPX) is a clinical-stage, oncology-focused biopharmaceutical company that has positioned itself at the forefront of the rapidly evolving field of antibody-based therapeutics. With a steadfast commitment to innovation and a deep understanding of the complex relationship between angiogenesis, the immune system, and tumor growth, Compass Therapeutics is poised to make a significant impact in the fight against cancer.
Compass Therapeutics was founded in 2014 as a private limited liability company with the ambitious goal of developing proprietary antibody-based treatments to address multiple human diseases, with a primary focus on oncology. The company's scientific approach is centered on leveraging its expertise in understanding the intricate interplay between angiogenesis, the immune system, and tumor growth. This holistic understanding has enabled Compass Therapeutics to design a pipeline of novel product candidates that target critical biological pathways required for an effective anti-tumor response.
In 2018, Compass Therapeutics entered into an exclusive global license agreement with ABL Bio, a South Korean biotechnology company, to develop tovecimig (formerly known as CTX-9), a bispecific antibody targeting DLL4 and VEGF-A. This strategic partnership allowed Compass to expand its pipeline and accelerate the development of this promising candidate.
In June 2020, Compass Therapeutics underwent a transformative merger with Olivia Ventures, Inc., a publicly-traded company, becoming a publicly-listed entity on the Nasdaq Capital Market under the ticker symbol CMPX. This strategic move provided Compass with additional capital to advance its pipeline of novel product candidates and access to public markets for future funding opportunities.
Over the subsequent years, Compass made steady progress in developing its clinical-stage assets. In 2023, the company completed enrollment in a Phase 2 trial evaluating tovecimig in patients with advanced colorectal cancer, although the trial did not meet the pre-specified criteria to advance to the second stage. Undeterred, Compass initiated a randomized Phase 2/3 trial of tovecimig in combination with paclitaxel in patients with biliary tract cancer, which completed enrollment in 2024.
During this period, Compass also advanced its earlier-stage pipeline, including CTX-471 and CTX-8371. The company presented promising preliminary data from the Phase 1 trial of CTX-471 at scientific conferences, identifying a potential biomarker of response. Additionally, Compass filed an IND and initiated a first-in-human Phase 1 study of CTX-8371 in 2024, further diversifying its clinical portfolio.
Product Pipeline
Compass Therapeutics' pipeline currently consists of three clinical-stage product candidates, along with one candidate in the investigational new drug (IND) enabling stage. The company's lead product candidate, tovecimig (formerly known as CTX-009), is a bispecific antibody that simultaneously targets Delta-like ligand 4 (DLL4) and vascular endothelial growth factor A (VEGF-A). This unique approach aims to modulate the tumor microenvironment by affecting both angiogenesis and immune response.
Tovecimig has demonstrated single-agent activity in heavily pre-treated patients with solid tumors who were resistant to anti-VEGF therapies, mostly of colorectal and gastric origins. The recommended phase 2 dose (RP2D) of tovecimig was determined to be 10 mg/kg and 12.5 mg/kg biweekly. In a Phase 2 trial conducted in South Korea, tovecimig in combination with paclitaxel demonstrated a 37.5% objective response rate (ORR) in patients with advanced biliary tract cancer (BTC) who had received one or two prior systemic therapies. Based on these results, Compass is conducting a randomized Phase 2/3 trial evaluating tovecimig in combination with paclitaxel in patients with advanced BTC in the United States.
The company's second program, CTX-471, is an agonistic antibody targeting the tumor necrosis factor receptor superfamily member 9 (TNFRSF9), also known as CD-137, a co-stimulatory receptor predominantly expressed on activated T-cells and natural killer (NK) cells. By activating CD-137, CTX-471 seeks to induce a potent immune response against tumor cells. In the Phase 1 trial, CTX-471 demonstrated monotherapy activity, including one complete response, in the post-PD-1/PD-L1 patient population across three solid tumor indications: melanoma, small cell lung cancer, and mesothelioma. Compass has identified neural cell adhesion molecule (NCAM) as a potential biomarker of activity for CTX-471 and plans to initiate a Phase 2 basket study evaluating CTX-471 in patients with NCAM-positive tumors in mid-2025.
Compass Therapeutics' third clinical-stage candidate, CTX-8371, is a bispecific antibody targeting the programmed cell death protein-1 (PD-1) and its ligand, PD-L1 – two well-established immune checkpoint targets. The company believes that this novel bispecific approach may offer improved anti-tumor activity compared to existing PD-1 and PD-L1 inhibitors. Preclinical studies have demonstrated that CTX-8371 has the ability to outperform PD-1, PD-L1, and combinations of the two in activating T-cells and controlling tumor growth in mouse models. Compass initiated a first-in-human Phase 1 clinical trial for CTX-8371 in April 2024, and as of January 2025, the third cohort of this trial had completed with no dose-limiting toxicities observed.
In addition to its clinical-stage assets, Compass Therapeutics is also advancing CTX-10726, a bispecific antibody targeting PD-1 and VEGF-A, through IND-enabling studies. This candidate is expected to leverage the company's experience in developing bispecific structures containing VEGF-A and PD-1 components. Compass is continuing IND-enabling studies for CTX-10726 and expects to file an IND by the end of 2025.
Financial Performance and Outlook
Compass Therapeutics reported its full-year 2024 financial results on February 27, 2025. The company's total revenue for the year amounted to $850,000, primarily attributable to a milestone payment received from its licensing partner, Elpiscience Biopharmaceuticals Co., Limited. This represented a significant increase compared to the previous year, as the company had not generated any revenue in 2023.
The company's research and development expenses increased by $4.22 million, from $38.12 million in 2023 to $42.34 million in 2024, reflecting the advancement of its clinical programs, particularly the lead candidate, tovecimig. General and administrative expenses also rose by $2.89 million, from $12.24 million in 2023 to $15.13 million in 2024, partly due to higher personnel costs associated with the CEO transition during the year.
For the full year 2024, Compass Therapeutics reported a net loss of $49.38 million, compared to a net loss of $45.89 million in 2023. The increase in net loss was primarily due to higher operating expenses as the company advanced its clinical programs. The annual operating cash flow for 2024 was negative $44.86 million, while the annual free cash flow was negative $44.90 million.
In the fourth quarter of 2024, Compass Therapeutics reported no revenue and a net loss of $10.48 million. The decrease in net income for the most recent quarter was primarily due to increased research and development expenses.
As of December 31, 2024, Compass Therapeutics had an accumulated deficit of $364.68 million. The company has funded its operations primarily through the sale of equity securities, raising gross proceeds of $430.5 million as of December 31, 2024.
Liquidity
As of December 31, 2024, Compass Therapeutics reported $126.70 million in cash, cash equivalents, and marketable securities, which the company believes will be sufficient to fund its operating expenses and capital expenditure requirements into the first quarter of 2027. This strong financial position provides the company with the necessary resources to continue advancing its pipeline and potentially pursuing additional strategic initiatives.
The company's liquidity position is further supported by its healthy balance sheet ratios. As of December 31, 2024, Compass Therapeutics had a debt-to-equity ratio of 0.05, indicating a low level of leverage. The company's current ratio and quick ratio both stood at 14.98, demonstrating a strong ability to meet short-term obligations.
Compass Therapeutics had $43.48 million in cash and cash equivalents and $83.24 million in marketable securities, for a total of $126.72 million in cash, cash equivalents and short-term investments. The company's current assets totaled $132.75 million, while current liabilities were $8.87 million, resulting in a strong working capital position.
In its latest guidance, Compass Therapeutics reaffirmed its commitment to several key milestones in 2025, including the expected top-line data readout from the randomized Phase 2/3 trial of tovecimig in patients with biliary tract cancer (BTC) by the end of the first quarter. The company also plans to initiate two Phase 2 trials in mid-2025, one evaluating tovecimig in DLL4-positive colorectal cancer (CRC) and another assessing CTX-471 in tumors expressing the neural cell adhesion molecule (NCAM/CD56) biomarker.
Risks and Challenges
As a clinical-stage biopharmaceutical company, Compass Therapeutics faces several risks and challenges inherent to the industry. The successful development and commercialization of its product candidates are subject to a variety of factors, including the ability to successfully complete preclinical studies and clinical trials, obtain regulatory approvals, and ultimately, manufacture and market the approved products.
The company's reliance on third-party contract research organizations (CROs) and contract manufacturing organizations (CMOs) to conduct its clinical trials and produce its drug candidates introduces additional risks related to timely completion of studies, compliance with regulatory requirements, and potential supply chain disruptions.
Furthermore, Compass Therapeutics operates in a highly competitive landscape, with established pharmaceutical and biotechnology companies actively developing their own oncology therapies. The company's ability to differentiate its products and maintain a competitive edge may impact its long-term success.
Lastly, the company's financial performance and ability to sustain operations are contingent on its capacity to raise additional capital through equity and debt financing, as well as potential collaborations and licensing agreements. Any failures or delays in securing the necessary funding could significantly impede Compass Therapeutics' growth and development plans.
Conclusion
Compass Therapeutics, with its innovative approach to targeting the complex interplay between angiogenesis, the immune system, and tumor growth, has the potential to make a significant impact in the field of oncology. The company's diverse pipeline of clinical-stage and preclinical candidates, coupled with its strong financial position, positions it well to navigate the challenges of the biopharmaceutical industry and deliver meaningful advancements in cancer treatment.
As Compass Therapeutics continues to execute on its strategic priorities, investors will closely monitor the progress of its lead candidate, tovecimig, as well as the development of its other promising therapies. With a focus on precision medicine and the utilization of novel biomarkers, the company is poised to contribute to the evolving landscape of oncology treatments and potentially improve outcomes for patients in need.