Intensity Therapeutics (NASDAQ:INTS) reported a wider second-quarter loss as research and development spending increased, while management outlined plans to restart enrollment in its Phase III sarcoma study and continue enrollment in its Phase II triple-negative breast cancer trial.
The company posted a net loss of $3 million for the second quarter of 2026, compared with a $2.5 million net loss in the year-earlier period. Research and development expense rose 19% to $1.8 million, driven largely by clinical trial costs. General and administrative expense increased 7% to $1.3 million.
Operating cash burn was $4.2 million in the first half, and the company expects operating cash burn to average about $1 million per month during the second half of 2026, Talamo said.
INVINCIBLE-3 Enrollment Restart Planned
President and CEO Lewis H. Bender said Intensity expects new patient enrollment in its Phase III INVINCIBLE-3 trial to begin within the next several months at a limited number of U.S. sites. The open-label, randomized trial is evaluating INT230-6 as a monotherapy against standard-of-care drugs in second- and third-line treatment of three soft-tissue sarcoma types.
The company had paused new site activations and enrollment in March 2025 because of funding constraints. During the pause, the 21 previously enrolled patients continued treatment or survival follow-up, while the company maintained trial safety and other required activities at a reduced cost.
Bender said the company amended the protocol following discussions with investigators and sarcoma specialists. The U.S. Food and Drug Administration reviewed the revised protocol. Among the changes, Intensity excluded patients with tumors larger than 15 centimeters and moved to a central review of scans to provide more consistent assessments of tumor progression.
Intensity is also preparing documentation to restart the study in France, Germany, Italy, Poland and Spain. The timing for activating additional U.S. and European sites will depend on raising additional capital.
Talamo estimated that completing INVINCIBLE-3 would require roughly $30 million over the next several years. He said the company does not currently have enough capital to immediately open all planned sites and regions, but intends to raise funds through its at-the-market facility and potentially through other financing or partnership arrangements.
Before the enrollment pause, more than 60 qualified sites across eight countries were either contracted or in contract negotiations, according to Bender.
Breast Cancer Study Resumes in Switzerland
Intensity also said its Phase II INVINCIBLE-4 trial resumed new patient treatment in Switzerland in July after Swissmedic and Swiss ethics committees authorized an amended protocol. The study is evaluating INT230-6 administered before standard immunochemotherapy in patients with early-stage operable triple-negative breast cancer.
Enrollment had been paused to review dosing after some patients experienced localized skin issues. Under the amended protocol, patients in the INT230-6 arm receive a single injection with reduced drug volume relative to the targeted tumor size.
Bender said the European Medicines Agency also authorized the revised protocol and that a site in France has been opened. The company is targeting completion of enrollment by the end of 2027, subject to site readiness and openings. About 45 additional patients are needed, he said.
In response to analyst questions, Bender said the company had treated “a couple” of patients under the amended regimen, in addition to 14 patients treated under the prior protocol. Intensity plans to add seven additional patients to the INT230-6 cohort to replace the seven previously treated under the earlier dosing approach.
Earlier preliminary data from 14 patients, with seven patients in each arm, showed a pathological complete response rate of 71% among patients receiving INT230-6 before standard treatment, compared with 42% for standard care alone. Bender said the groups were randomized and balanced, but noted the data were early. He also cited a trend toward fewer Grade 3 adverse events, including immune-related events, in the INT230-6 cohort.
Publications and Partnership Discussions
Bender highlighted a November publication in EBioMedicine, a Lancet Group journal, describing results from the company’s Phase I/II IT-01 study of INT230-6 as a monotherapy in metastatic or refractory cancers.
According to Bender, the publication reported a 75% disease-control rate and median overall survival of nearly 12 months among 64 patients with more than 20 metastatic cancer types. Patients had progressed after a median of three prior therapies. He said patients receiving treatment to more than 40% of their visible tumor burden had median overall survival of 18.7 months.
The company is pursuing additional peer-reviewed publications for completed studies, Bender said.
Intensity also held more than 20 meetings with potential strategic partners at the BIO International Convention in San Diego in late June. Bender characterized the discussions as early-stage and said potential structures range from global rights arrangements with multinational companies to regional partnerships.
“We are evaluating all the options,” Bender said, adding that the company expects to continue discussions during the second half of 2026.
About Intensity Therapeutics (NASDAQ:INTS)
Intensity Therapeutics, Inc, a clinical-stage biotechnology company, engages in the discovery, development, and commercialization of cancer drugs to treat solid tumors. The company's lead product candidate is INT230-6, which is in Phase 2 clinical trial for the treatment of refractory solid tumors; and pancreatic, colon, bile duct, squamous cell carcinoma, sarcoma, breast, and liver cancers. It has a collaboration agreement with Merck Sharpe & Dohme Corp. to evaluate the combination of INT230-6 and Keytruda in patients with advanced pancreatic, colon, squamous cell, and bile duct malignancies; Bristol-Myers Squibb Company to evaluate the combination of INT230-6 with Yervoy in patients with advanced liver, breast, and sarcoma cancers; and Ottawa Hospital Research Institute and the Ontario Institute of Cancer Research to study INT230-6 in a randomized controlled neoadjuvant phase II study in women with early-stage breast cancer.
