Compass Therapeutics Reports 2023 Financial Results and Provides Corporate Update
Compass Therapeutics, Inc. provided an update on their clinical trials for CTX-009, CTX-471, and CTX-8371, reporting progress in enrollment and potential biomarkers. Financially, the company ended 2023 with $152 million in cash and marketable securities, extending their cash runway into mid-2026.
Positive
Enrollment in COMPANION-002 for CTX-009 in advanced biliary tract cancer is progressing well, with top-line data expected by end of 2024.
Completed enrollment in COMPANION-003 for CTX-009 in advanced colorectal cancer, with top-line data expected by mid-2024.
Initiated planning for a Phase 2 study of CTX-471 in advanced melanoma patients with a newly identified biomarker.
Began enrollment of patients in the combination arm of CTX-471 with KEYTRUDA® Phase 1b study.
Initiated Phase 1 first-in-human study for CTX-8371, expecting to dose first patient by early second quarter.
Reported full 2023 financial results, ending the year with $152 million in cash and marketable securities, extending cash runway into mid-2026.
Negative
Net loss for 2023 was $42.5 million, an increase from $39.2 million in 2022.
R&D expenses increased by $8.1 million primarily due to higher clinical and manufacturing costs for CTX-009.
G&A expenses increased by $0.6 million, mainly due to higher stock compensation expense.
Cash position decreased by $34.1 million in 2023, primarily from net cash used in operating activities.
The ongoing clinical trials for CTX-009 and CTX-471, as well as the initiation of the first-in-human study for CTX-8371, represent significant milestones in Compass Therapeutics' oncology pipeline. The focus on advanced biliary tract cancer (BTC) and colorectal cancer (CRC) with CTX-009 and advanced melanoma with CTX-471, addresses areas with high unmet medical needs. The identification of a biomarker for CTX-471 activity could potentially lead to a more targeted and effective treatment approach for melanoma patients. As these trials progress, investors should monitor the patient response rates and the safety profiles of these therapies, as positive data could lead to increased market confidence and potential partnerships or licensing deals.
Furthermore, the financial stability of Compass Therapeutics, with a cash runway extending into mid-2026, provides a buffer for continued research and development without the immediate need for additional capital raises. This financial position can be attractive to investors, as it suggests a lower risk of dilution in the near term. However, the reported net loss for 2023 and the increased R&D expenses, in line with the development of their clinical programs, are typical for clinical-stage biopharmaceutical companies and should be evaluated in the context of potential long-term gains from successful product commercialization.
The financial results reported by Compass Therapeutics indicate a strategic allocation of resources towards advancing their lead clinical programs. The increase in R&D expenses by 27% reflects the company's commitment to pushing these programs through critical phases of clinical trials. While this does result in a net loss, which is not uncommon for clinical-stage biotech companies, the longer-term cash runway into 2026 suggests prudent financial management.
Investors should consider the implications of the trial outcomes on the company's valuation. Positive top-line data from these studies could significantly enhance the company's prospects and stock valuation, while any setbacks could have the opposite effect. The cash position is a key metric, as it provides insight into the company's ability to sustain operations and fund ongoing trials without the immediate pressure to secure additional financing, which could be a positive signal for stock stability.
Compass Therapeutics operates in the competitive and high-stakes field of oncology drug development. The progression of their clinical trials and the entrance into new phases is a critical factor that could influence their market position. The advanced BTC and CRC markets, along with melanoma therapies, are areas with significant growth potential and successful outcomes from Compass's trials could position the company as a strong player in these segments.
The anticipated data releases in mid and end of 2024 are events that the market will be watching closely, as they could be inflection points for the company's stock. The development of a bispecific antibody like CTX-8371 also reflects the industry's trend towards innovative cancer treatments with potentially higher efficacy and specificity. The strategic focus on these areas could, in the long run, lead to substantial market share in these oncology segments if the trials prove successful and the treatments receive regulatory approval.
03/21/2024 - 09:00 AM
Enrollment in COMPANION-002, the Phase 2/3 randomized study of CTX-009 (DLL4 x VEGF-A bispecific antibody) in patients with advanced biliary tract cancer (BTC), continues to progress well; top-line data from this study are expected by the end of 2024. Enrollment in COMPANION-003, the Phase 2 study of CTX-009 in patients with advanced colorectal cancer (CRC) was completed in the first quarter of 2024; top-line data from Stage 1 of this study are expected by mid-year 2024. Initiated planning of a Phase 2 monotherapy study of CTX-471 (CD137 agonist antibody) in patients with advanced melanoma whose tumors express a newly identified biomarker of CTX-471 activity. Additionally, enrollment of patients in the combination arm of CTX-471 with KEYTRUDA® Phase 1b study is ongoing . Advanced CTX-8371 (PD-1 x PD-L1 bispecific antibody) into Phase 1 first-in-human study and expect to dose first patient by early second quarter. Ended 2023 with $152 million in cash and marketable securities, which is expected to provide cash runway into mid-year 2026. BOSTON, March 21, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today reported full 2023 financial results and provided business update.
“2023 was an important year for Compass as we strategically shifted our focus toward the clinical development of our lead program, CTX-009, which is currently being evaluated in patients with advanced biliary tract cancer and advanced colorectal cancer,” said Vered Bisker-Leib, PhD, Chief Executive Officer. “This year we expect to report top-line data from Stage 1 of the Phase 2 COMPANION-003 trial by mid-year and top-line data from our Phase 2/3 COMPANION-002 trial by the end of the year. Our balance sheet remains strong and we ended the year with $152 million , extending our cash runway into the middle of 2026.”
“In 2023, we made significant progress across our clinical programs,” said Thomas Schuetz, MD, PhD, Co-Founder and President of Research & Development at Compass. “In the monotherapy study of CTX-471, our novel CD137 agonist antibody, we reported additional partial responses in patients with advanced melanoma, a complete response in a patient with small cell lung cancer, and a partial response in a patient with mesothelioma, all of whom had previously progressed on a checkpoint blocker. Importantly, we have identified a potential biomarker of response in biopsy specimens from this study and we are now planning a Phase 2 study in patients whose tumors express this biomarker. We also initiated the combination arm of the CTX-471 with KEYTRUDA®
Development Pipeline Updates:
CTX-009 (DLL4 and VEGF-A bispecific antibody)
Continue to enroll patients in COMPANION-002, a U.S. Phase 2/3 randomized study of CTX-009 in combination with paclitaxel in patients with advanced BTC. This study is designed to enroll 150 patients who have received one prior systemic therapy. The primary endpoint of the study is overall response rate (ORR), and secondary endpoints include progression free survival (PFS), overall survival (OS), clinical benefit rate (CBR) and duration of response (DOR). Enrollment is expected to be completed by mid-year 2024; top-line data are expected by year end 2024. Completed enrollment of patients in Stage 1 of COMPANION-003, a U.S. Phase 2 study of CTX-009 as a monotherapy in patients with advanced, metastatic CRC. The study design is an Adaptive Simon Two-Stage. Stage 1 of the study enrolled 37 patients with CRC who have received two or three prior systemic therapies irrespective of their KRAS mutation status. Top-line data is expected by mid-year 2024. If adequate efficacy is observed in Stage 1, the study will continue to Stage 2 where 47 additional patients are expected to be enrolled. CTX-471 (CD137 agonist antibody)
CTX-471 is a CD137 agonist antibody, which binds to a unique epitope of the co-stimulatory molecule 4-1BB with an optimized affinity. In the Phase 1B monotherapy study, five responses were observed, all in patients who previously received checkpoint inhibitors. A durable partial response (PR) in a patient with SCLC has converted to a complete response (CR), as confirmed by a PET scan. Additionally, a new PR in a patient with advanced melanoma, was observed, leading to an objective response rate (ORR) in the subset of patients with advanced melanoma of 27% (3 of 11). The fifth response occurred in a patient with mesothelioma. Ongoing analysis of biopsy specimens from the Phase 1b study revealed a potential biomarker of response. As a result, planning for a Phase 2 monotherapy study in patients with melanoma whose tumors express this biomarker is underway. Ongoing enrollment of up to 60 patients in the Phase 1b dose-expansion cohort of the combination arm of CTX-471 and Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) with melanoma, NSCLC and SCLC, who will be randomly assigned to one of two doses. CTX-8371 (PD-1 x PD-L1 bispecific antibody)
CTX-8371 is a next generation bispecific checkpoint inhibitor that simultaneously targets PD-1 and PD-L1 and exhibits a unique mechanism-of-action that involves cleavage of cell surface PD-1. Following the FDA acceptance of the IND for CTX-8371, clinical sites were opened and the first patient is expected to be dosed by early second quarter. Financial Results
Net loss for the year ended December 31, 2023, was $42.5 million or $0.33 per common share, compared to $39.2 million or $0.37 per common share for the same period in 2022.
Research and Development (R&D) Expenses
R&D expenses were $38.1 million for the year ended December 31, 2023, as compared to $30.0 million for the same period in 2022, an increase of $8.1 million or 27% . This increase was primarily attributable to a $10.7 million increase in clinical and manufacturing costs related to our lead program, CTX-009.
General and Administrative (G&A) Expenses
G&A expenses were $12.2 million for the year ended December 31, 2023, as compared to $11.7 million for the same period in 2022, an increase of $0.6 million or 5% . The increase was primarily attributable to higher stock compensation expense of $1.0 million offset by lower insurance costs of $0.3 million .
Cash Position
As of December 31, 2023, cash and marketable securities were $152.5 million as compared to $186.6 million as of December 31, 2022, providing the Company with an anticipated cash runway into mid-2026. During 2023, the Company decreased its cash position by $34.1 million , primarily from $40.6 million of net cash used in operating activities.
About Compass Therapeutics https://www.compasstherapeutics.com .
Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Compass’s financial position to continue advancing its product candidates, expectations about cash runway, business and development plans, and statements regarding Compass’s product candidates, including their development and clinical trial milestones such as the expected trial design, timing of enrollment, patient dosing and data readouts, regulatory plans with respect to Compass’s product candidates and the therapeutic potential thereof. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, Compass’s ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass’s ability to identify additional product candidates for development, Compass’s ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statements are made as of the date of this press release, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the U.S. Securities and Exchange Commission (SEC) available at www.sec.gov , including without limitation Compass’s latest Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC.
Investor Contact ir@compasstherapeutics.com Media Contact media@compasstherapeutics.com
Compass Therapeutics, Inc. and Subsidiaries Three Months Ended December 31, Year Ended December 31, 2023 2022 2023 2022 (unaudited) Operating expenses: Research and development $ 12,428 $ 9,929 $ 38,120 $ 29,997 General and administrative 2,961 2,959 12,243 11,658 Total operating loss (15,389 ) (12,888 ) (50,363 ) (41,655 ) Other income 1,974 1,294 7,869 2,430 Net loss $ (13,415 ) $ (11,594 ) $ (42,494 ) $ (39,225 ) Net loss per share - basic and diluted $ (0.11 ) $ (0.10 ) $ (0.33 ) $ (0.37 ) Compass Therapeutics, Inc. and Subsidiaries December 31, 2023 2022 Assets Current assets: Cash and cash equivalents $ 24,228 $ 34,946 Marketable securities 128,233 151,663 Prepaid expenses and other current assets 1,420 8,182 Total current assets 153,881 194,791 Property and equipment, net 898 1,567 Operating lease, right-of-use ("ROU") asset 1,776 2,967 Other assets 320 320 Total assets $ 156,875 $ 199,645 Liabilities and Stockholders' Equity Current liabilities: Accounts payable $ 4,090 $ 3,382 Accrued expenses 2,514 11,690 Operating lease obligations, current portion 1,197 1,097 Total current liabilities 7,801 16,169 Operating lease obligations, long-term portion 536 1,838 Total liabilities 8,337 18,007 Total stockholders' equity 148,538 181,638 Total liabilities and stockholders' equity $ 156,875 $ 199,645
What is the status of enrollment in COMPANION-002 for CTX-009?
Enrollment is progressing well, with top-line data expected by the end of 2024.
When is the expected top-line data release for COMPANION-003 for CTX-009?
Top-line data from Stage 1 of this study are expected by mid-year 2024.
What study is Compass Therapeutics planning for CTX-471?
They are planning a Phase 2 monotherapy study in patients with advanced melanoma whose tumors express a newly identified biomarker of CTX-471 activity.
What is the financial status of Compass Therapeutics at the end of 2023?
They ended 2023 with $152 million in cash and marketable securities, extending their cash runway into mid-2026.
What was the net loss for Compass Therapeutics in 2023?
The net loss for 2023 was $42.5 million, compared to $39.2 million in 2022.
Why did R&D expenses increase in 2023?
R&D expenses increased by $8.1 million primarily due to higher clinical and manufacturing costs related to CTX-009.
What caused the increase in G&A expenses in 2023?
G&A expenses increased by $0.6 million, mainly due to higher stock compensation expense.
How much did Compass Therapeutics' cash position decrease in 2023?
The cash position decreased by $34.1 million in 2023, primarily from net cash used in operating activities.
