Intensity Therapeutics (NASDAQ:INTS) reported a wider third-quarter loss as it resumed clinical trial activities for its experimental cancer drug INT230-6, while executives said additional funding will determine how quickly the company can expand enrollment.
The company ended September with $8.5 million in cash and cash equivalents and expects operating cash use to average approximately $1 million a month in the fourth quarter. Intensity is evaluating additional financing and potential partnerships as it advances studies in soft tissue sarcoma and triple-negative breast cancer.
Loss Widens as Clinical Spending Rises
Intensity’s net loss increased to $3.5 million in the third quarter of 2026 from $2.7 million a year earlier. Research and development expenses rose to $2.4 million from $1.6 million, while general and administrative expenses were unchanged at $1.3 million, Chief Financial Officer Joseph Talamo said.
Spending on the Phase 3 INVINCIBLE-3 sarcoma study rose to $1.5 million from $1 million. Talamo said the company resumed new-patient enrollment activities at a limited number of U.S. sites after pausing enrollment and new site activations in March 2025 because of funding constraints. Previously enrolled patients continued to receive treatment and monitoring during the pause.
Intensity also began manufacturing a new batch of INT230-6. Talamo said the batch is expected to be completed in the first quarter of 2027 and will likely be sufficient to supply both ongoing studies.
Operating cash use was $6.7 million for the first nine months of 2026. The company raised $1.5 million in net proceeds through its at-the-market stock offering facility during the third quarter and $3.2 million through the facility over the nine-month period. Talamo said 2027 spending will depend largely on additional capital and the pace of enrollment.
Sarcoma Trial Restart Depends on Funding
INVINCIBLE-3 is an open-label, randomized study comparing INT230-6 alone with standard treatments in second- and third-line patients with three types of soft tissue sarcoma. President and CEO Lewis Bender said several U.S. sites are active and seeking patients, but no newly identified patients had yet been randomized; they were undergoing screening.
The company filed documentation to restart the trial in Europe and Canada in the third quarter and expects approval to begin under an amended protocol in Europe in the first quarter of 2027. Bender said the pace of additional site activations and enrollment will depend on capital raised.
“Capital will be the gating factor on how quickly we enroll,” Bender said.
Intensity also changed how disease progression will be assessed in the trial, adopting the Choi imaging criteria and a central review of CT scans. Bender said physicians recommended the change after observing that tumors could increase in size following injection while becoming necrotic and cystic. Under the previous protocol, size increases could require patients to leave treatment.
The Choi criteria will be used for both the INT230-6 and standard-of-care groups. Overall survival remains the study’s primary endpoint, Bender said.
Breast Cancer Study Targets 2027 Enrollment Completion
Intensity resumed dosing new patients in its Phase 2 INVINCIBLE-4 study during the third quarter after enrollment was paused late last year to revise dosing in response to localized skin issues. The study tests a single dose of INT230-6 before standard neoadjuvant immunochemotherapy against standard treatment alone in patients with early-stage operable triple-negative breast cancer.
Bender cited previously reported early results showing a pathological complete response rate of 71% among patients who received INT230-6, compared with 42% for standard care. He cautioned that the findings involved very small numbers and were early data. A pathological complete response means no live cancer is detected at surgery in the tumor, breast or lymph nodes.
An independent group of experts will review safety data and images from newly treated patients to assess whether the revised dosing regimen has resolved the skin issues. Bender said the review will focus on images of the skin over several months.
The company continues to target completion of INVINCIBLE-4 enrollment by the end of 2027. Bender said that plan currently relies on sites in France and Switzerland and does not require U.S. sites.
Partnership Talks Remain Early
Bender said Intensity is discussing potential partnerships with several multinational and regional companies, though the conversations remain at an early evaluation stage. A key objective would be to secure a partner to fund part or all of the programs in exchange for a license, he said.
The company has also submitted manuscripts based on its completed INVINCIBLE-2 breast cancer study and its IT-01 metastatic cancer study. Both have been accepted for peer review, and Intensity is addressing reviewers’ comments. Bender said the company hopes the papers will be published before the second quarter of 2027, subject to reviewer and editor approval.
About Intensity Therapeutics (NASDAQ:INTS)
Intensity Therapeutics, Inc (NASDAQ: INTS) is a clinical-stage biotechnology company developing investigational cancer immunotherapies designed to treat solid tumors. Its approach focuses on injecting therapies directly into tumors to promote tumor-cell destruction and stimulate a broader immune response against cancer.
The company’s lead product candidate, INT230-6, is a proprietary formulation containing the chemotherapy agents cisplatin and vinblastine combined with an amphiphilic delivery agent.
