Intensity Raises $20M, Extends Runway to Q2 2027; 71% pCR in TNBC

INTSINTS

Intensity raised over $20 million in 2025 and held $11.9 million in cash, extending its operating runway into Q2 2027. Preliminary INVINCIBLE-4 data showed 71.4% pathological complete response versus 33% with standard care and 44% fewer grade ≥3 adverse events in TNBC patients.

1. 2025 Year-End Results and Cash Runway

Intensity raised over $20 million in 2025 through equity offerings and held $11.9 million in cash and equivalents as of December 31, 2025, extending its operating runway into the second quarter of 2027. Research and development expenses declined to $6.8 million from $10.5 million in 2024.

2. INVINCIBLE-4 Study Preliminary Efficacy and Safety

In the Phase 2 INVINCIBLE-4 trial for early-stage operable triple negative breast cancer, 71.4% of patients receiving INT230-6 before standard of care achieved pathological complete response versus 33% in the control arm, with 44% fewer grade 3 or higher adverse events. Full enrollment resumed in Switzerland on March 26, 2026, following regulatory approval.

3. IT-01 Phase 1/2 Manuscript Highlights

The Phase 1/2 IT-01 study demonstrated a 75% disease control rate and median overall survival of 11.9 months in 64 refractory metastatic cancer patients, with a 21.3-month median survival in a sarcoma subset. Patients treated on over 40% of their tumor burden saw an 83.3% disease control rate, 18.7-month median survival and notable abscopal responses, with no dose-limiting toxicities reported.

4. INVINCIBLE-3 Enrollment Pause and Plans

The Phase 3 INVINCIBLE-3 trial in second- and third-line soft tissue sarcoma paused new site activations in March 2025 due to funding constraints after enrolling 21 patients. The company continues patient treatment and data management at reduced cost, aiming to resume enrollment in 2026 once additional funding is secured.

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