On November 10, 2026 Context Therapeutics Inc. ("Context" or the "Company") (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging ("TCE") bispecific antibodies for solid tumors, reported 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.

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Longer-term Phase 1 follow-up showed median progression-free survival ("PFS") of 5.6 months at biologically active weekly doses of 140–280 µg. 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 µg or higher. CTIM-76 was generally well tolerated, supporting further Q3W dose escalation from 280 µg to 420 µg. 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 µg (n=21) or Q3W at 280 µg (n=6).
Fifteen patients with PROC were treated at biologically active doses, either 140 to 280 µg QW (n=9) or 280 µg 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-γ 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 µg 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 µg Q3W is complete (n=6 patients), and dose escalation to 420 µg Q3W (n=3–6) has begun. An additional 6 patients are being enrolled at 280 µg 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.

(Press release, Context Therapeutics, NOV 11, 2026, View Source [SID1234674632])