CTIM-76 weekly dosing at 140--280 ug in heavily pretreated PROC: 22% confirmed ORR,
56% confirmed DCR, and median PFS of 5.6 months
Dose escalation to 420 ug every three weeks is ongoing following completion of the DLT assessment period at 280 ug
Phase 1b initiation expected in Q1 2027 and initial Q3W efficacy data in Q2 2027
Cash and cash equivalents of $34.4 million as of September 30, 2026 expected to fund operations to early Q4 2027
PHILADELPHIA, Nov. 10, 2026 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. ("Context" or the "Company") (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging ("TCE") bispecific antibodies for solid tumors, today announced its financial results for the third quarter ended September 30, 2026, and reported on recent and upcoming business highlights. The Company also reported longer-term follow-up from weekly ("QW") dosing and initial safety from every-three-week ("Q3W") dosing in the ongoing Phase 1 trial of CTIM-76, its Claudin 6 ("CLDN6") x CD3 TCE.
Longer-term Phase 1 follow-up showed median progression-free survival ("PFS") of 5.6 months at biologically active weekly doses of 140--280 ug. An emerging association between dose, cytokine and T cell activation, and tumor shrinkage is informing dose selection as the Company optimizes every-three-week dosing and advances toward Phase 1b at a dose of 280 ug or higher. CTIM-76 was generally well tolerated, supporting further Q3W dose escalation from 280 ug to 420 ug. Activity extended to liver metastases, which are typically difficult to treat with immunotherapy:(1) all seven liver target lesions decreased in size, including two that disappeared completely. While preliminary, these efficacy, pharmacodynamic and tolerability findings support continued development of CTIM-76 and further evaluation of its potential as a best-in-class TCE for platinum-resistant ovarian cancer ("PROC").
"CTIM-76 continues to show promising activity in patients with PROC who had received a median of six prior lines of therapy," said Martin Lehr, Chief Executive Officer of Context. "Our Phase 1b strategy is to evaluate CTIM-76 in patients with no more than five prior lines of therapy. These less heavily pretreated patients generally have lower tumor burden and better T cell fitness,(2) providing a rationale to evaluate whether treatment in this population, together with Q3W dosing, can deliver greater clinical benefit and improved tolerability.(3) We view the results to date as an initial benchmark, with Phase 1b providing an opportunity to further define CTIM-76's clinical potential."
Recent Pipeline Progress and Upcoming Milestones of Prioritized Clinical Programs:
CTIM-76: CLDN6 x CD3 TCE
Context is evaluating CTIM-76 as a monotherapy in a Phase 1 trial in patients with CLDN6-positive PROC, testicular and endometrial cancers. The U.S. FDA has granted Fast Track designation to CTIM-76 for patients with PROC who have received all standard-of-care therapies.
Patients
-- As of October 30, 2026, 27 patients with ovarian (n=20), testicular (n=4)
and endometrial (n=3) cancer had received CTIM-76 in dose escalation
cohorts, either QW at 22.5 to 560 ug (n=21) or Q3W at 280 ug (n=6).
-- Fifteen patients with PROC were treated at biologically active doses,
either 140 to 280 ug QW (n=9) or 280 ug Q3W (n=6). These patients had
received a median of 6 prior lines of therapy (range, 3--16), and 12
(80%) had received a prior antibody-drug conjugate ("ADC") therapy,
including 5 (33%) who had received two or more ADCs.
Efficacy
-- Among efficacy evaluable PROC patients treated QW at biologically active
doses (n=9), the confirmed objective response rate ("ORR") was 22% and
the disease control rate ("DCR") was 56%. Two patients (22%) achieved a
confirmed partial response and 3 (33%) had stable disease.
-- As of October 30, 2026, median PFS was 5.6 months (95% CI: 1.2--7.4
months) among efficacy-evaluable PROC patients treated QW at biologically
active doses.
-- Tumor reduction was observed across metastatic sites, including
regression of 7 liver lesions in 4 patients (median -58%; range -16% to
-100%).
-- Patients treated with Q3W dosing continue to be followed; initial Q3W
efficacy data are expected in Q2 2027.
Pharmacokinetics and Pharmacodynamics
-- Exposure increased approximately dose-proportionally, and the
pharmacokinetic profile supports evaluation of Q3W dosing.
-- CTIM-76 demonstrated dose-dependent induction of IFN-<GAMMA> and IL-2,
with higher peak cytokine levels and CD69+ CD8 T cell activation observed
in patients with tumor reduction, providing clinical pharmacodynamic
evidence consistent with the proposed mechanism of target-dependent T
cell activation.
Safety
-- Cytokine release syndrome occurred in 5 of 27 patients (18.5%); all
events were Grade 1 or 2.
-- Grade >=3 treatment-emergent adverse events occurred in 22 of 27 patients
(81.5%) overall. The most common were increased gamma-glutamyl
transferase (GGT; 37.0%), increased aspartate aminotransferase (AST;
29.6%), increased alanine aminotransferase (ALT; 22.2%), increased lipase
(18.5%), and anemia (14.8%).
-- Grade >=3 liver enzyme elevations were dose-related, occurring most
frequently at 560 ug QW. At biologically active doses, Grade >=3 AST and
ALT elevations each occurred in 4 patients (21.1%). Hepatic enzyme
elevations generally occurred early in treatment, were asymptomatic, and
resolved with continued dosing.
Dose Escalation and Backfill
-- The dose-limiting toxicity ("DLT") evaluation period at 280 ug Q3W is
complete (n=6 patients), and dose escalation to 420 ug Q3W (n=3--6) has
begun. An additional 6 patients are being enrolled at 280 ug Q3W to
further characterize that dose level.
Upcoming Expected Milestones:
-- Q1 2027: Initiation of Phase 1b dose expansion -- Q2 2027: Phase 1a initial efficacy data with Q3W dosing in PROC patients
CT-202: Nectin-4 x CD3 TCE
Context is evaluating CT-202 as a monotherapy in a Phase 1 trial in patients with urothelial, colorectal and triple-negative breast cancers.
Recent Progress:
-- September 2026: First patient dosed in Phase 1 trial -- Six sites are active in Australia
Upcoming Expected Milestones:
-- 2H 2027: Phase 1a initial data
-- U.S. investigational new drug application filing on track by year-end
2026
Third Quarter 2026 Financial Results
-- Cash and cash equivalents were $34.4 million at September 30, 2026,
compared to $66.0 million at December 31, 2025. The Company expects its
cash and cash equivalents will be sufficient to fund its operations to
early fourth quarter of 2027.
-- Research and development expenses were $5.7 million for the third quarter
of 2026, compared to $8.7 million for the third quarter of 2025. The
decrease was primarily driven by a $3.9 million reduction in CT-202
expenses, reflecting lower contract manufacturing and preclinical
expenses. Higher CTIM-76, CT-95 and personnel-related costs partially
offset this reduction.
-- General and administrative expenses were $2.2 million for the third
quarter of 2026, as compared to $1.9 million for the third quarter of
2025. The increase was primarily driven by higher salaries and
personnel-related costs, including share-based compensation as compared
to the same period in 2025.
-- Other income was $0.3 million for the third quarter of 2026, as compared
to $0.9 million for the third quarter of 2025, primarily due to lower
interest income earned on cash and cash equivalent balances.
-- Context reported a net loss of $7.6 million for the third quarter of
2026, as compared to $9.7 million for the third quarter of 2025.
References
1 Yu, J., Green, M.D., Li, S. et al. Liver metastasis restrains immunotherapy efficacy via macrophage-mediated T cell elimination. Nature Medicine 27, 152--164 (2021).
2 Cooper AJ, Sands J. T-cell engagers in small cell lung cancer. Cancer. 2026 Sep 15;132(18):e70600.
3 Sands J, et al. Tarlatamab plus durvalumab versus durvalumab alone in extensive-stage small-cell lung cancer: a phase 3 trial. New England Journal of Medicine. 2026;385(18):1623-1634.
About Context Therapeutics(R)
Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T cell engaging ("TCE") bispecific antibodies for solid tumors. Context's goal is to build an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 TCE, and CT-202, a Nectin-4 x CD3 TCE. Context is headquartered in Philadelphia, PA. For more information, please visit www.contexttherapeutics.com or follow the Company on X (formerly Twitter) and LinkedIn.
Forward-looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including statements regarding the Company's strategy, future operations, prospects, and plans and objectives of management, are forward-looking statements. These statements may be identified by words such as "may," "will," "expect," "believe," "could," "estimate," "potential," "anticipate," "look forward," "plan," "intend," and similar expressions.
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