- Opened 29 clinical sites and continue to enroll patients in COMPANION-002, a
U.S. Phase 2/3 study of CTX-009 in combination with Paclitaxel in patients with advanced biliary tract cancers (BTC); top line data from this study is expected in the second half of 2024 - Continue to enroll and follow patients in COMPANION-003, a
U.S. Phase 2 study of CTX-009 (DLL4 /VEGF-A bispecific antibody) in patients with advanced colorectal cancer (CRC); initial data from this study is expected before the end of the year - Received IND clearance for CTX-8371, a next generation bispecific checkpoint inhibitor that simultaneously targets PD-1 and PD-L1; anticipate initiating a first-in-human clinical study in the fourth quarter of 2023
- Announces a CEO succession plan;
Vered Bisker-Leib , PhD, Compass President and COO, to transition to Compass Chief Executive Officer and join Compass board of directors andThomas Schuetz , MD, PhD, Compass’ Scientific Founder and Chief Executive Officer, to transition to President of Research and Development and appointed Vice Chair of the Compass board of directors. Transition to take place onJanuary 9 th 2024 - Ended the third quarter with
$164 million in cash and marketable securities, providing cash runway for the company into 2026
“Enrollment in our Phase 2/3 study, COMPANION-002, in patients with advanced BTC has increased in the third quarter in part based on our opening of several clinical sites at large academic medical centers around the country. In addition, data are continuing to evolve in our COMPANION-003 study in patients with advanced CRC, and we expect to report initial data from this study in the fourth quarter of this year,” said
“We are very excited to announce that the FDA cleared the IND for CTX-8371, our PD-1 and PD-L1 bispecific antibody, the first StitchMabs® generated bispecific to advance to the clinic. We believe this next generation checkpoint inhibitor with its unique mechanism-of-action may have improved activity compared with first generation checkpoint blockers in a range of solid tumors. We look forward to initiating a first-in-human clinical study prior to the end of the year,” said
Development Pipeline Update and Highlights:
CTX-009 (DLL4 and VEGF-A bispecific antibody)
- Enrolling patients in a
U.S. Phase 2 study of CTX-009 as a monotherapy in patients with advanced, metastatic CRC (COMPANION-003)- The study design is an Adaptive Simon Two-Stage, with Stage 1 of the study enrolling 37 patients; if 3 or more responses are confirmed in Stage 1, the study will advance to Stage 2, and an additional 47 patients will be enrolled
- The study is enrolling patients with CRC who have received two or three prior systemic therapies irrespective of their KRAS mutation status
- Patients are being evaluated for safety and tolerability, as well as clinical response
- Initial results from Stage 1 of this study are expected in the fourth quarter of 2023
- Enrolling patients in a
U.S. Phase 2/3 study of CTX-009 in combination with Paclitaxel in BTC (COMPANION-002)- This randomized Phase 2/3 study is designed to enroll 150 patients with BTC 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 in the third quarter has increased relative to the first half of 2023 in part due to the opening of several clinical sites at large academic medical centers across the country
- Top line data is expected from this study in the second half of 2024
CTX-471 (CD137 + PD-1)
- This Phase 1 study is assessing the safety and activity of the combination of CTX-471 (CD137 agonistic antibody) and Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with select solid tumors
- The dose-escalation portion of the study (n=9) has been completed with no dose limiting toxicities observed
- The cohort expansion phase of the trial is expected to begin in in the first quarter of 2024
CTX-8371 (PD-1 x PD-L1)
- 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
- FDA cleared the IND for CTX-8371 and we expect to initiate a Phase 1 clinical trial in the fourth quarter of 2023
Financial Results
Net loss for the third quarter ended
Cash Position
As of
Research and development (R&D) Expenses
R&D expenses were
R&D expenses were
General and Administrative (G&A) Expenses
G&A expenses were
Upcoming Investor Conferences
Compass management will participate in two upcoming investor conferences:
Stifel Healthcare Conference
Date:November 14-15, 2023
Location:New York, NY
Jefferies London Healthcare Conference
Date:November 14-16, 2023
Location:London, UK
Live webcasts presentations, when available, will be under “News & Events” in the Investors section of the Company’s website located at www.compasstherapeutics.com.
KEYTRUDA® is a registered trademark of
About
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, their development, regulatory plans with respect thereto and 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
Investor Contact
ir@compasstherapeutics.com
Media Contact
media@compasstherapeutics.com
617-500-8099
Condensed Consolidated Statements of Operations (unaudited)
(In thousands, except per share data)
Three Months Ended | Nine Months Ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 8,831 | $ | 9,791 | $ | 25,694 | $ | 20,069 | |||||||
General and administrative | 3,095 | 2,807 | 9,276 | 8,698 | |||||||||||
Total operating expenses | 11,926 | 12,598 | 34,970 | 28,767 | |||||||||||
Loss from operations | (11,926 | ) | (12,598 | ) | (34,970 | ) | (28,767 | ) | |||||||
Other income | 1,962 | 623 | 5,891 | 1,136 | |||||||||||
Net loss | $ | (9,964 | ) | $ | (11,975 | ) | $ | (29,079 | ) | $ | (27,631 | ) | |||
Net loss per share - basic and diluted | $ | (0.08 | ) | $ | (0.12 | ) | $ | (0.23 | ) | $ | (0.27 | ) | |||
Condensed Consolidated Balance Sheets
(In thousands)
2023 | 2022 | ||||||
(unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 30,426 | $ | 34,946 | |||
Marketable securities | 133,277 | 151,663 | |||||
Prepaid expenses and other current assets | 2,881 | 8,182 | |||||
Total current assets | 166,584 | 194,791 | |||||
Property and equipment, net | 1,051 | 1,567 | |||||
Operating lease, right-of-use ("ROU") asset | 2,083 | 2,967 | |||||
Other assets | 320 | 320 | |||||
Total assets | $ | 170,038 | $ | 199,645 | |||
Liabilities and Stockholders' Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 2,306 | $ | 3,382 | |||
Accrued expenses | 5,644 | 11,690 | |||||
Operating lease obligations, current portion | 1,174 | 1,097 | |||||
Total current liabilities | 9,124 | 16,169 | |||||
Operating lease obligations, long-term portion | 869 | 1,838 | |||||
Total liabilities | 9,993 | 18,007 | |||||
Total stockholders' equity | 160,045 | 181,638 | |||||
Total liabilities and stockholders' equity | $ | 170,038 | $ | 199,645 | |||
Source:
2023 GlobeNewswire, Inc., source