- Initiated
U.S. Phase 2/3 study of CTX-009 (DLL4 /VEGF-A bispecific antibody) in patients with advanced biliary tract cancers (BTC); initial results are expected in the first half of 2024
- Initiated
U.S. Phase 2 study of CTX-009 in patients with advanced colorectal cancer (CRC) and dosed the first patient; initial results expected in the third quarter of 2023 - Presented results of the Phase 2 study of CTX-009 in combination with paclitaxel in patients with BTC at the 2023 ASCO GI Cancers Symposium
- Completed enrollment of the Phase 1 monotherapy arm of CTX-471 (CD137 agonistic antibody) and initiated enrollment in the combination arm of CTX-471 with KEYTRUDA® (pembrolizumab) in patients with select solid tumors; initial combination results are expected in the second half of 2023
- Completed GMP manufacturing and toxicology studies of CTX-8371 (PD-1 /PD-L1 bispecific antibody) in non-human primates; IND submission on track and planned for the first half of 2023
- Ended 2022 with
$187 million in cash and marketable securities providing cash runway for the company into 2026, including$80 million in gross proceeds raised in a private investment in public equity (PIPE) financing executed inNovember 2022
“Compass made tremendous progress last year as we advanced the development of our three drug candidate programs. Importantly, we initiated two key studies with CTX-009: a Phase 2/3 study in patients with biliary tract cancers and a Phase 2 study in patients with advanced colorectal cancer,” said
“Completing the
Development Pipeline Update and Highlights:
CTX-009 (DLL4 and VEGF-A bispecific antibody)
- Presented Phase 2 results of CTX-009 in combination with paclitaxel in patients with BTC at the 2023 ASCO GI Cancers Symposium
- Data showed 9 confirmed partial responses (PRs) for an overall response rate (ORR) of 37.5% in the second and third line settings (n= 24 patients dosed)
- In the second line setting, an ORR of 63.6% in 11 patients treated was observed
- Median progression free survival (PFS) was 9.4 months and median overall survival (OS) was 12.5 months
- Safety and tolerability were consistent with prior studies
- In
January 2023 , announced first patient dosed in theU.S. Phase 2 study of CTX-009 as a monotherapy in patients with metastatic colorectal cancer- The study design is an Adaptive Simon Two-Stage, with Stage 1 of the study enrolling 37 patients. If there are 3 or more responses confirmed in Stage 1, the study will advance to Stage 2 and an additional 47 patients will be enrolled
- Patients are being evaluated for safety and tolerability, as well as clinical response
- Initial results from this study are expected in the third quarter of 2023
- Initiated
U.S. Phase 2/3 study of CTX-009 in combination with Paclitaxel in BTC- The study will enroll 150 patients with BTC who have received one prior systemic therapy, randomized 2:1 to receive either CTX-009 combined with paclitaxel or paclitaxel alone
- The primary endpoint of the study is ORR, and secondary endpoints include PFS, OS, clinical benefit rate (CBR) and duration of response (DOR)
- Initial results from this study are expected in the first half of 2024
CTX-471 (CD137 agonistic monoclonal antibody)
- Generated monotherapy evidence of activity for CTX-471
- Phase 1 of CTX-471 in patients with various metastatic or locally advanced solid tumors who initially benefited from a checkpoint blocker has been fully enrolled
- Four PRs were observed in the monotherapy arm of the Phase 1 study, three of which were confirmed by RECIST 1.1
- In
November 2022 , opened and dosed the first patient in the combination arm of the study of the Phase 1 study of CTX-471 with KEYTRUDA®- This arm of the study is enrolling patients with metastatic or locally advanced cancers of the lung, head and neck and melanoma who have progressed after treatment with a checkpoint inhibitor. Patients enrolled in the study are treated with CTX-471 in combination with KEYTRUDA® with the goal of restoring a response
- CTX-471 is supplied by Compass, which is the sponsor of the study, and KEYTRUDA® is provided by Merck under a clinical trial collaboration and supply agreement
- Initial results from the combination arm are expected in the second half of 2023
CTX-8371 (PD-1 and PD-L1 bispecific antibody)
- Completed GMP manufacturing campaign and toxicology studies in non-human primates
- An investigational new drug (IND) application is on track and planned for the first half of 2023
Financial Results
Net loss for the year ended
Research and development (R&D) Expenses
R&D expenses were
General and Administrative (G&A) Expenses
G&A expenses were
Cash Position
As of
Upcoming Investor Conferences
Compass management will participate at four upcoming investor conferences:
- Cantor’s The Future of Oncology Virtual Symposium
Date:April 3-5, 2023
Location: virtual
- Stifel’s Virtual Targeted Oncology Event
Date:April 25-26, 2023
Location: virtual
Inaugural EF Hutton Global Conference
Date:May 10-11, 2023
Location:The Plaza Hotel ,New York, NY
- 2023
World Medical Innovation Forum (Bank of America andMass General )
Date:June 12-14, 2023
Location:Westin Seaport District ,Boston
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
Media Contact
media@compasstherapeutics.com
617-500-8099
Investor Contact
ir@compasstherapeutics.com
Consolidated Statements of Operations
(In thousands, except per share data)
Three Months Ended | Year Ended | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Operating expenses: | (unaudited) | ||||||||||||||
Research and development | $ | 9,929 | $ | 9,574 | $ | 29,997 | $ | 20,337 | |||||||
General and administrative | 2,959 | 3,426 | 11,658 | 10,927 | |||||||||||
In Process R&D | — | — | — | 50,618 | |||||||||||
Total operating expenses | 12,888 | 13,000 | 41,655 | 81,882 | |||||||||||
Loss from operations | (12,888 | ) | (13,000 | ) | (41,655 | ) | (81,882 | ) | |||||||
Other income (expense), net | 1,294 | 7 | 2,430 | (299 | ) | ||||||||||
Loss before income tax expense | (11,594 | ) | (12,993 | ) | (39,225 | ) | (82,181 | ) | |||||||
Income tax expense | — | 13 | — | — | |||||||||||
Net loss | $ | (11,594 | ) | $ | (12,980 | ) | $ | (39,225 | ) | $ | (82,181 | ) | |||
Net loss per share - basic and diluted | $ | (0.10 | ) | $ | (0.15 | ) | $ | (0.37 | ) | $ | (1.31 | ) | |||
Condensed Consolidated Balance Sheets (In thousands, except par value) | |||||||||||||||
2022 | 2021 | ||||||||||||||
Assets | |||||||||||||||
Current assets: | |||||||||||||||
Cash and cash equivalents | $ | 34,946 | $ | 144,514 | |||||||||||
Marketable securities | 151,663 | — | |||||||||||||
Prepaid expenses and other current assets | 8,182 | 2,591 | |||||||||||||
Total current assets | 194,791 | 147,105 | |||||||||||||
Property and equipment, net | 1,567 | 2,243 | |||||||||||||
Operating lease, right-of-use ("ROU") asset | 2,967 | 4,089 | |||||||||||||
Other assets | 320 | 320 | |||||||||||||
Total assets | $ | 199,645 | $ | 153,757 | |||||||||||
Liabilities and Stockholders' Equity | |||||||||||||||
Current liabilities: | |||||||||||||||
Accounts payable | $ | 3,382 | $ | 867 | |||||||||||
Accrued expenses | 11,690 | 8,775 | |||||||||||||
Operating lease obligations, current portion | 1,097 | 989 | |||||||||||||
Total current liabilities | 16,169 | 10,631 | |||||||||||||
Operating lease obligations, long-term portion | 1,838 | 3,048 | |||||||||||||
Total liabilities | 18,007 | 13,679 | |||||||||||||
Total stockholders' equity | 181,638 | 140,078 | |||||||||||||
Total liabilities and stockholders' equity | $ | 199,645 | $ | 153,757 | |||||||||||
Source:
2023 GlobeNewswire, Inc., source