Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage,
oncology-focused biopharmaceutical company developing proprietary
antibody-based therapeutics to treat multiple human diseases, today
reported fourth quarter and full year 2022 financial results.
“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 Thomas J. Schuetz, MD, PhD,
Co-Founder and Chief Executive Officer. “We look forward to initial
results from the CTX-009 colorectal study and the CTX-471
combination study later this year and in 2024 for CTX-009 in
BTC.”
“Completing the $80 million PIPE offering in the fourth quarter
of 2022 has positioned us well to reach key milestones over the
next year with continued investment in our pipeline programs,” said
Vered Bisker-Leib, PhD, MBA, President and Chief Operating
Officer.
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 the U.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 December 31, 2022, was $39.2 million
or $0.37 per share, compared to $82.2 million or $1.31 per share
for the same period in 2021. The net loss for 2021 includes $50.6
million non-recurrent in-process R&D expense related to the
acquisition of TRIGR Therapeutics which was completed in June
2021.
Research and development (R&D) Expenses
R&D expenses were $30.0 million for the year ended December
31, 2022, as compared to $20.3 million for the same period in 2021,
an increase of $9.7 million or 47%. The increase for the year was
primarily attributable to $10.3 million of project costs related to
our three development programs (CTX-009, CTX-471 and CTX-8371)
resulting from increased clinical, manufacturing, and toxicology
activities.
General and Administrative (G&A) Expenses
G&A expenses were $11.7 million for the year ended December
31, 2022, as compared to $10.9 million for the same period in 2021,
an increase of $0.7 million or 7%. The increase was primarily
attributable to a higher stock compensation expense of $1.2
million, partially offset by lower legal costs of $0.5 million.
Cash Position
As of December 31, 2022, cash and marketable securities were
$186.6 million as compared to $144.5 million as of December 31,
2021, providing the Company with an anticipated cash runway into
2026. During 2022, the Company increased its cash position by $80.3
million from financing activities that generated net proceeds of
$75.8 million. The Company used $34.1 million of cash to fund
operations.
Upcoming Investor Conferences
Compass management will participate at four upcoming investor
conferences:
- Cantor’s The
Future of Oncology Virtual SymposiumDate: April 3-5,
2023Location: virtual
- Stifel’s
Virtual Targeted Oncology EventDate: April 25-26,
2023Location: virtual
- Inaugural EF
Hutton Global Conference Date: May 10-11, 2023Location:
The Plaza Hotel, New York, NY
- 2023 World
Medical Innovation Forum (Bank of America and Mass
General)Date: June 12-14, 2023Location: 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 Merck Sharp & Dohme
LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ,
USA.
About Compass Therapeutics
Compass Therapeutics, Inc. is a clinical-stage oncology-focused
biopharmaceutical company developing proprietary antibody-based
therapeutics to treat multiple human diseases. Compass’s scientific
focus is on the relationship between angiogenesis, the immune
system, and tumor growth. The company pipeline of novel product
candidates is designed to target multiple critical biological
pathways required for an effective anti-tumor response. These
include modulation of the microvasculature via
angiogenesis-targeted agents, induction of a potent immune response
via activators on effector cells in the tumor microenvironment, and
alleviation of immunosuppressive mechanisms used by tumors to evade
immune surveillance. Compass plans to advance its product
candidates through clinical development as both standalone
therapies and in combination with proprietary pipeline antibodies
based on supportive clinical and nonclinical data. The company was
founded in 2014 and is headquartered in Boston, Massachusetts. For
more information, visit the Compass Therapeutics website
at 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, 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 SEC available at www.sec.gov, including
without limitation Compass’s latest Form 10-Q and subsequent
filings with the SEC.
Media Contact Anna Gifford, Communications
Manager media@compasstherapeutics.com617-500-8099
Investor Contact ir@compasstherapeutics.com
Compass Therapeutics, Inc. and
SubsidiariesConsolidated Statements of Operations(In thousands,
except per share data)
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
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 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compass Therapeutics, Inc. and SubsidiariesCondensed Consolidated
Balance Sheets(In thousands, except par value) |
|
December 31, |
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Compass Therapeutics (NASDAQ:CMPX)
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Compass Therapeutics (NASDAQ:CMPX)
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