Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage,
oncology-focused biopharmaceutical company developing proprietary
antibody-based therapeutics to treat multiple human diseases, today
reported third quarter and year-to-date, 2023 financial results.
“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 Vered Bisker-Leib, PhD, President and
Chief Operating Officer.
“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 Thomas J. Schuetz, MD, PhD, Co-Founder and
Chief Executive Officer.
Carl Gordon, Chairman of Compass’ Board of Directors, “Vered is
a seasoned biotech executive who has played a key role in building
our pipeline and operations, and she is well positioned to lead
Compass through this next phase of strategic growth. Additionally,
Tom’s expertise and leadership as President of Research and
Development will be invaluable as we continue to deliver on our
mission of advancing next generation antibodies into transformative
cancer therapies. Both Vered and Tom’s commitment to Compass over
the past decade have been instrumental in the value creation of the
company, and I look forward to continuing our work together.”
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 September 30, 2023 was
$10.0 million or $0.08 per common share, compared to $12.0 million
or $0.12 per common share for the same period in 2022. Net loss for
the nine months ended September 30, 2023 was $29.1 million or $0.23
per common share, compared to $27.6 million or $0.27 per common
share for the same period in 2022.
Cash Position
As of September 30, 2023, cash and marketable securities were
$164 million as compared to $187 million as of December 31, 2022,
providing the Company with an anticipated cash runway into 2026.
During the first nine months of 2023, the Company used $28 million
of cash to fund operations.
Research and development (R&D) Expenses
R&D expenses were $8.8 million for the quarter ended
September 30, 2023, as compared to $9.8 million for the same period
in 2022, a decrease of approximately $1.0 million or 10%. The
decrease was primarily attributable to lower manufacturing expense
related to CTX-009 of $1.6M.
R&D expenses were $25.7 million for the nine months ended
September 30, 2023, as compared to $20.1 million for the same
period in 2022, an increase of $5.6 million or 28%. The increase
was primarily attributable to higher clinical costs of $3.8 million
and higher manufacturing costs of $1.1 million.
General and Administrative (G&A) Expenses
G&A expenses were $3.1 million for the quarter ended
September 30, 2023, as compared to $2.8 million for the same period
in 2022, an increase of $0.3 million or 10%. The increase was
primarily attributable to higher stock compensation expense of $0.3
million. G&A expenses were $9.3 million for the nine months
ended September 30, 2023, as compared to $8.7 million for the same
period in 2022, an increase of $0.6 million or 7%. The increase was
primarily attributable to higher stock compensation expense of $0.5
million.
Upcoming Investor Conferences
Compass management will participate in two upcoming investor
conferences:
- Stifel
Healthcare ConferenceDate: November 14-15, 2023Location:
New York, NY
- Jefferies
London Healthcare ConferenceDate: November 14-16,
2023Location: 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 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.
Investor Contactir@compasstherapeutics.com
Media Contact Anna Gifford, Communications
Manager media@compasstherapeutics.com617-500-8099
Compass Therapeutics, Inc. and
SubsidiariesCondensed Consolidated Statements of Operations
(unaudited)(In thousands, except per share data)
|
Three Months EndedSeptember
30, |
|
Nine Months EndedSeptember
30, |
|
|
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 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Compass Therapeutics, Inc. and
SubsidiariesCondensed Consolidated Balance Sheets(In thousands)
|
September 30,2023 |
|
December 31,2022 |
|
(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 |
|
|
|
|
|
|
|
|
|
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