Intensity Therapeutics, Inc.

What they do

The company develops patented anti-cancer product candidates made of active anti-cancer agents combined with amphiphilic molecules using non-covalent conjugation chemistry. Its lead candidate, INT230-6, combines cisplatin, vinblastine sulfate and an amphiphilic molecule (SHAO) in one vial for direct intratumoral injection, designed to disperse through a tumor and diffuse into cancer cells. The company has run the Phase 1/2 IT-01 study in refractory or metastatic cancers (110 patients) and Phase 2 INVINCIBLE-2 in early-stage breast cancer (91 subjects), and is now running the Phase 3 INVINCIBLE-3 soft tissue sarcoma study and Phase 2 INVINCIBLE-4 triple negative breast cancer study.

Revenue drivers

• INT230-6 — Sole clinical-stage product candidate; no product sales have been generated to date, so it contributes no revenue. All value depends on clinical success and eventual approval.
• DfuseRx discovery platform — Platform that creates the company's anti-cancer candidates by mixing active agents with amphiphilic molecules. Described as the source of patented candidates but has not produced revenue.
• At-the-market (ATM) equity facility — The company's current source of cash is equity issuance, not operations. A $60 million ATM facility was established in March 2026; $1.6 million net was raised in Q2 2026 and $1.3 million net after June 30, 2026.

Recent performance

The company reported no revenue and a net loss of $11.6 million for 2025, narrower than the $16.3 million loss in 2024. Operating cash flow was negative $9.2 million in 2025 versus negative $15.2 million in 2024. As of June 30, 2026, total assets were $11.5 million, total liabilities $2.3 million, shareholder equity $9.2 million, and cash and cash equivalents $9.5 million. Diluted EPS was negative $8.56 in 2025 compared with negative $29.24 in 2024.

Strategy

Management is restarting clinical activity after funding-driven pauses: in April 2026 it initiated activities to resume enrollment in a limited number of U.S. sites in the Phase 3 INVINCIBLE-3 sarcoma study under an FDA-reviewed amended protocol, with EU restart documentation in progress. In July 2026 it restarted patient treatment in the Phase 2 INVINCIBLE-4 TNBC study after a protocol amendment lowering drug volume per tumor volume and using a single injection, and opened its first French site in August 2026. The company targets complete INVINCIBLE-4 enrollment by the end of 2027 and says site activation and enrollment rates depend on obtaining sufficient funding. It is also increasing business development activities and has funded operations through a $60 million ATM facility, raising $1.6 million net in Q2 2026 and $1.3 million net after quarter-end.

Risks

• Going concern — The independent registered public accounting firm's report for the year ended December 31, 2025 contains a statement about substantial doubt as to the company's ability to continue as a going concern due to recurring losses and negative operating cash flows.
• No product revenue or approval — The company has a limited operating history and has not generated any revenue from product sales, so it depends on financing and clinical success.
• Funding-dependent enrollment — INVINCIBLE-3 enrollment was paused in March 2025 due to funding constraints, and the company states that site activation and enrollment rates are expected to increase only as sufficient funding is obtained.
• Safety/tolerability events — INVINCIBLE-4 enrollment was paused in September 2025 after some patients receiving INT230-6 in Cohort A experienced localized skin irritation near the tumor site, requiring a dosing regimen amendment.

Outlook

Management says capital raised in 2025 and to date in 2026 provides resources to reinitiate the Phase 3 INVINCIBLE-3 study, with the FDA-reviewed amended protocol first implemented in select U.S. sites. It expects INVINCIBLE-4 complete enrollment by the end of 2027 and continues EU restart documentation for INVINCIBLE-3. The company reports increased business development activities and states that further site activation and enrollment depend on obtaining sufficient funding.