PHILADELPHIA, PA — Context Therapeutics Inc. (Nasdaq: CNTX) reported third-quarter 2025 financial results and provided an update on its pipeline of bispecific T cell engager (TCE) programs, highlighting early signs of safety and antitumor activity across multiple clinical trials.
The company’s lead candidate, CTIM-76, a CLDN6 x CD3 bispecific TCE, continues to advance in Phase 1 dose escalation for patients with ovarian, endometrial, and testicular cancers. As of October 30, 2025, 12 patients had been enrolled, with dosing progressing to Cohort 5. Preliminary results show early antitumor activity, including an ongoing RECIST response, with no cases of cytokine release syndrome above Grade 1 or dose-limiting toxicities. A maximum tolerated dose has not been reached.
“We believe the early clinical data for CTIM-76 provides encouraging early signs of antitumor activity for Context’s T cell engagers in solid tumors where many other approaches have failed due to material safety issues or lack of efficacy,” said Martin Lehr, CEO of Context. “We look forward to continuing to advance Context’s clinical trials and providing more detailed updates in 2026.”
Based on current safety data, Context plans to continue dose escalation for CTIM-76 with the goal of deepening clinical responses while maintaining a favorable safety profile. The company anticipates releasing updated interim Phase 1a data and dose selection results in the second quarter of 2026.
The company also reported progress on its second TCE program, CT-95, which targets mesothelin (MSLN). The Phase 1 study, currently enrolling Cohort 3, is approaching target dose levels. Six patients have been enrolled to date, with no dose-limiting toxicities or cytokine release syndrome above Grade 2. Context expects to share initial Phase 1a data by mid-2026.
In addition, CT-202, a Nectin-4 x CD3 bispecific TCE, remains in preclinical development. The therapy has shown pH-dependent activity in preclinical studies—targeting acidic tumor environments while sparing healthy tissue. Context plans to file regulatory documents to begin first-in-human trials in the second quarter of 2026.
For the third quarter of 2025, Context reported cash and cash equivalents of $76.9 million, compared to $94.4 million at the end of 2024. The company projects its current resources will fund operations into 2027.
Research and development expenses totaled $8.7 million, down from $16.8 million in the same period last year, reflecting lower costs tied to CT-202 and CT-95 following earlier licensing and acquisition charges. General and administrative expenses remained steady at $1.9 million.
Overall, Context reported a net loss of $9.7 million, an improvement from the $17.5 million loss reported in the third quarter of 2024.
With multiple programs advancing in parallel, Context expects 2026 to be a pivotal year, marked by key data readouts and its first regulatory filings to bring novel T cell engager therapies to patients with hard-to-treat solid tumors.
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