-- As recently announced, tovecimig (DLL4 x VEGF-A bispecific antibody) in
combination with paclitaxel demonstrated a highly statistically
significant improvement in progression-free survival $(PFS)$ versus
paclitaxel alone as well as clear signals of a survival benefit in a
Phase 2/3 study of patients with biliary tract cancer $(BTC)$; tovecimig
previously met the primary endpoint of overall response rate $(ORR)$.
-- Tovecimig received Orphan Drug Designation in April and the Company
intends to meet with the FDA in advance of its planned BLA submission
later this year.
-- The Phase 1 dose-escalation study of CTX-8371 (PD-1 x PD-L1 bispecific
antibody) has been selected for a poster presentation at the American
Society of Clinical Oncology (ASCO) 2026 Annual Meeting, highlighting
three deep responses (TNBC, NSCLC, HL) in patients treated in the
post-checkpoint inhibitor setting; cohort expansions in these indications
have been initiated.
-- The Phase 1 study for CTX-10726 (PD-1 x VEGF-A bispecific antibody) has
also been initiated in the post-checkpoint inhibitor setting, with
initial data expected [Q4 2026].
-- $195 million in cash and marketable securities at Q1 2026, which is
expected to fund operations into 2028.
BOSTON, May 05, 2026 (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 first quarter 2026 financial results and provided a business update.
"We recently announced positive data from our Phase 2/3 study of tovecimig and look forward to meeting with the FDA before filing a BLA later this year. Most patients with BTC have no approved therapeutic option in the second line setting. Tovecimig, with its strong response rate, striking progression benefit and impact on overall survival would be a compelling treatment alternative for these patients," said Thomas Schuetz, MD, PhD, Chief Executive Officer and Vice Chairman of the Board of Directors."
"In the post-checkpoint inhibitor setting where treatment alternatives are also critically needed, we have ongoing studies with very two promising candidates. Our novel PD-1 x PD-L1 checkpoint inhibitor CTX-8371 continues to demonstrate strong and durable clinical activity and we look forward to presenting dose-escalation and early expansion cohort data at ASCO. CTX-10726, our differentiated PD-1 x VEGF-A bispecific antibody, is also in a Phase 1 study and we expect to share initial data later this year."
Pipeline Updates:
Tovecimig (DLL4 and VEGF-A bispecific antibody)
In April 2026, the Company announced data from its Phase 2/3 study of tovecimig, which it plans to include in a BLA submission, to treat patients with biliary tract cancer in the second line setting:
-- Overall Response Rate (primary endpoint): 17.1% for tovecimig combination
(n=111), including one complete response, compared to 5.3% for paclitaxel
alone (n=57)(p=0.031).
-- Progression-Free Survival (secondary endpoint): 4.7 months for tovecimig
combination compared to 2.6 months for paclitaxel alone (HR=0.44,
p<0.0001).
-- Overall Survival (secondary endpoint): Analysis was confounded by high
crossover from the control arm (n=31) and markedly prolonged survival of
these crossover patients after receiving tovecimig. The OS of the
patients randomized to the tovecimig combination arm (n=111), which does
not include the OS of these crossover patients later treated with
tovecimig, was a median of 8.9 months.
-- PFS Before / After Crossover (secondary endpoint): Patients treated with
tovecimig after crossing from the control arm progressed after a median
3.5 months (PFS2) in the third line setting. These same 31 patients, when
initially randomized to paclitaxel alone (PFS1), had progressed more
quickly, with a median of 1.9 months in the second line setting (HR=0.36,
p=0.0016).
-- OS Crossover vs. Non-Crossover (post hoc subset analysis): In an analysis
of OS in all patients initially randomized to the paclitaxel control arm
(n=57), crossover patients who subsequently received tovecimig
demonstrated a statistically significant improvement in median OS of 12.8
months compared to 6.1 months for non-crossover patients who received
only paclitaxel (n=26)(HR=0.54, p=0.04).
-- Pooled OS of All Patients Treated with Tovecimig (post hoc subset
analysis): For all patients treated with tovecimig, including both
crossover patients and patients initially randomized to the tovecimig
combination arm (n=142), the pooled median OS was 9.8 months. The median
OS for patients randomized to the paclitaxel alone who did not crossover
(n=26) was 6.1 months.
-- Safety: Tovecimig was generally well tolerated and the safety profile was
consistent with prior studies, with no new safety signals identified.
The investigator sponsored trial (IST) of tovecimig in combination with the current first-line, standard-of-care regimen of gemcitabine, cisplatin, and durvalumab in patients with BTC (NCT05506943) is ongoing. The Company is evaluating multiple additional studies for tovecimig in other indications, including both ISTs and Company-sponsored studies.
CTX-8371 (PD-1 x PD-L1 bispecific antibody)
-- Cohort expansions for CTX-8371 have been initiated in patients with
triple-negative breast cancer (TNBC, n=28), non-small cell lung cancer
(NSCLC, n=28), and Hodgkin lymphoma (HL, n=12) in the post-checkpoint
inhibitor setting. These indications were selected based on the deep and
durable responses observed in these indications in the dose escalation
portion of the study. Half of the patients with each tumor type will be
dosed at 3.0 mg/kg and half will be dosed at 10.0 mg/kg.
-- Initial data from these cohort expansions, as well as available data from
the Phase 1 dose-escalation portion of the study, will be presented at
ASCO 2026. Additional data from the cohort expansions are expected in the
fourth quarter of 2026.
CTX-10726 (PD-1 x VEGF-A bispecific antibody)
-- The Phase 1 study has been initiated with clinical data expected in the
fourth quarter of 2026.
-- The Phase 1 multiple ascending dose-escalation study will include four
doses (0.3, 1.0, 3.0, and 10.0 mg/kg) in a 3+3 dose-escalation design.
The multi-center study will enroll patients with a prioritized set of
solid tumor indications, including patients with locally advanced,
unresectable or metastatic renal cell carcinoma, gastroesophageal cancer,
hepatocellular carcinoma, and endometrial cancer, in whom standard of
care therapies have failed.
-- CTX-10726 is a tetravalent PD-1 x VEGF-A bispecific antibody discovered
and engineered by the Company. CTX-10726 exhibits more potent PD-1
blockade compared with data reported for other drugs in the class and the
Company believes it has a unique understanding of aspects of its
mechanism of action that will guide development.
CTX-471 (CD137 or 4-1BB agonist antibody)
-- Initiation of the Phase 2 trial of CTX-471 in patients with tumors
expressing NCAM (CD56) is expected in the second half of 2026.
Financial Results
Net loss for the quarter ended March 31, 2026, was $18.3 million or $0.10 per common share, compared to $16.6 million or $0.12 per common share for the same period in 2025.
Research and Development (R&D) Expenses
R&D expenses were $13.4 million for the quarter ended March 31, 2026, as compared to $13.1 million for the same period in 2025, an increase of $0.3 million or 3%.
General and Administrative (G&A) Expenses
G&A expenses were $6.9 million for the quarter ended March 31, 2026, as compared to $4.9 million for the same period in 2025, an increase of $2.0 million or 41%. The increase was primarily driven by pre-commercialization expenses of $1.0 million and higher stock compensation (excluding stock compensation related to pre-commercialization) of $1.4 million.
Cash Position
As of March 31, 2026, cash and marketable securities were $195 million as compared to $209 million as of December 31, 2025, a decrease of $14 million, with an anticipated cash runway into 2028. During the first quarter of 2026, $18 million of net cash was used in operating activities, and this was partially offset by proceeds from exercise of common stock of $4 million.
About Compass Therapeutics
Compass Therapeutics, Inc. is a clinical-stage oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth. Compass has built a robust pipeline of novel product candidates designed to target multiple critical biological pathways required for an effective anti-tumor response. These pathways 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. The company 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
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