INTS

Cash and cash equivalents of $10.2 million as of March 31, 2026 Favorable efficacy and safety reported in a small sample of triple negative breast cancer ("TNBC") patients receiving INT230-6 prior to the standard of care ("SOC") compared to SOC alone in the INVINCIBLE-4 Study (as defined below) Approval to resume enrollment obtained in the INVINCIBLE-4 Study; plans to resume enrollment in the second quarter of 2026 Decision to resume enrollment in a limited number of U.S. sites in the INVINCIBLE-3 Study (as defined below) by the third quarter of 2026 SHELTON, Conn., May 7, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, announces first quarter 2026 financial results and provides a corporate update. Corporate Update INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC treatment in patients with early-stage, operable triple negative breast cancer and SOC alone. In March 2026, the Company reported the following: Preliminary observations of the INVINCIBLE-4 Study showed that five (5) out of seven (7) patients (71.4%) who received INT230-6 prior to SOC ("Cohort A") achieved a pathological complete response ("pCR") whereas two (2) out of six (6) (33%) patients in the SOC arm alone ("Cohort B") achieved a pCR, with one patient still to be evaluated. Forty-four percent (44%) fewer grade 3 or higher adverse events were observed in Cohort A compared to Cohort B. A protocol amendment was submitted to Swissmedic, Switzerland's regulatory authority, and the Switzerland Ethics Committee to resume enrollment. Full approval to resume enrollment was granted on March 26, 2026. The Company plans to resume enrollment in the second quarter of 2026. The Company expects presentation of more detailed results for the seven (7) Cohort A patients at a future oncology conference. INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second- and third-line treatment for specific soft tissue...

Raised over $20 million in gross proceeds in 2025 and held $11.9 million in cash and cash equivalents as of December 31, 2025, with a cash runway into the second quarter of 2027 IT-01 Study manuscript of INT230-6 used alone in 64 refractory metastatic cancer patients published in the Lancet's journal eBioMedicine, including data for disease control rate, overall survival, immune activation, abscopal effects, tumor necrosis, dose ranging, and safety Favorable efficacy and safety reported in a small sample of triple negative breast cancer ("TNBC") patients receiving INT230-6 prior to the standard of care ("SOC") compared to SOC alone in the INVINCIBLE-4 Study SHELTON, Conn., March 27, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, announces 2025 year-end financial results and highlights, and provides a corporate update. Corporate Update INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC treatment in patients with early-stage, operable triple negative breast cancer and SOC alone. In March 2026, the Company reported the following: Preliminary observations of the INVINCIBLE-4 Study showed that five (5) out of seven (7) patients (71.4%) who received INT230-6 prior to SOC ("Cohort A") achieved a pathological complete response ("pCR") whereas two (2) out of six (6) (33%) patients in the SOC arm alone ("Cohort B") achieved a pCR, with one patient still to be evaluated. Forty-four percent (44%) fewer grade 3 or higher adverse events were observed in Cohort A compared to Cohort B. A protocol amendment was submitted to Swissmedic, Switzerland's regulatory authority, and the Switzerland Ethics Committee to resume enrollment. Full approval to resume enrollment was granted on March 26, 2026. The Company expects presentation of more detailed results for the seven (7) Cohort A patients at a future oncology conference. INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in secon...

The Company expects to file a protocol amendment in the INVINCIBLE-4 Study to revise the dosing regimen for the INT230-6 treatment cohort, and to reinitiate patient enrollment in the first quarter of 2026 IT-01 Study manuscript published, featuring a comprehensive evaluation of data, including disease control rate, overall survival, immune activation, abscopal effects, tumor necrosis, dose ranging, and safety $7.1 million cash and cash equivalents as of September 30, 2025, with an incremental $6.1 million raised in the fourth quarter of 2025 Cash runway extended until the end of the first quarter of 2027 SHELTON, Conn., Nov. 6, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, announces third quarter 2025 financial results and provides a corporate update. Corporate Update INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care ("SOC") treatment in patients with early-stage, operable triple-negative breast cancer and SOC alone. The primary endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. In October 2024, in collaboration with the Swiss Cancer Group, formerly the Swiss Cancer Group for Clinical Cancer Research (SAKK), the Company initiated and dosed our first patient in the INVINCIBLE-4 Study. In September 2025, the Company paused new patient enrollment to revise the dosing regimen for patients receiving INT230-6 in cohort A due to some patients in Cohort A experiencing localized skin irritation near the tumor site. The Company plans to file a protocol amendment for this revision in dosing in the first quarter of 2026, and expects to reinitiate enrollment for the 54-patient study in the first quarter of 2026. The Company is targeting to complete enrollment by the end of 2026 and will likely add resources to help sites enroll. INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second- and thi...

The paper features a comprehensive evaluation of data, including disease control rate, overall survival, immune activation, abscopal effects, tumor necrosis, dose ranging, and safety The manuscript is open access The Company will host a webinar with the paper's lead and senior authors from the University of Southern California to discuss the results on Friday, October 31, 2025, at 9:00 AM (see below) SHELTON, Conn., Oct. 30, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary cancer therapies using its non-covalent, drug-conjugation technology that creates drug products designed to kill tumors and increase immune system recognition of cancers, announces that eBioMedicine, a Lancet Discovery Science journal, has published the Company's phase 1/2 IT-01 clinical study manuscript for the treatment of metastatic or refractory cancers. The full text article, "Safety and Efficacy of Intratumourally Administered INT230-6 in Adult Patients with Advanced Solid Tumours: Results from an Open-Label Phase 1/2 Dose Escalation Study," can be viewed via Online First 105980 October 29, 2025. Jacob Stephen Thomas, M.D. Assistant Professor of Clinical Medicine at Keck School of Medicine of the University of Southern California (USC) and medical oncologist with USC's Norris Comprehensive Cancer Center, is the first author. Anthony El-Khoueiry, M.D., Associate Director for Clinical Research and Chief of Section of Developmental Therapeutics/Phase I Program at USC Norris, is the senior and corresponding author. The manuscript includes the following data results: In heavily pretreated patients with advanced disease having over 20 different types of cancer who had progressed following multiple prior lines of therapy, intratumoral INT230-6 achieved: A disease control rate of 75% (48/64 patients) and median overall survival (mOS) of 11.9 months; these results compare favorably in phase 1/2 studies that historically reported an mOS of 4 to 7 months In a metastatic sarcoma subset population receiving only INT230-6, the median overall survival was 21.3 months In an exploratory analysis comparing patients receiving INT230-6 at a total dose (in mL) that treated greater than 40% of the patient's total tumour burden ("TTB") compared to those treated...

Over $11 million raised since the beginning of 2Q 2025 Cash runway extended into the second half of 2026 In the INVINCIBLE-4 Study, patients receiving INT230-6 prior to the start of standard of care achieved high levels of tumor necrosis in 8 days INT230-6 achieved 100% complete response rate in preclinical models of malignant peripheral nerve sheath tumors SHELTON, Conn., Aug. 7, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, announces second quarter 2025 financial results and provides a corporate update. Corporate Update INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care ("SOC") treatment in patients with early-stage, operable triple-negative breast cancer and SOC alone. The primary endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. In April, the European Medicines Agency authorized the initiation of the INVINCIBLE-4 Study in France in collaboration with Unicancer (UCBG), the French referent cooperative group in breast cancer accredited by the French National Cancer Institute (INCa). The INVINCIBLE-4 Study is currently recruiting patients in Switzerland and France. The expected total is 54 patients. In June 2025 we showed images from the trial of a patient who received two doses of INT230-6. Prior to the injections, the tumor was active. In the post INT230-6 injection scans, the tumor became dark with only diminished live cancer observed at the interface of the healthy tissue and necrotic tumor. INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second and third line treatment for specific soft tissue sarcoma subtypes. This study has been authorized by the US FDA, Health Canada, the European Medicines Agency (for France, Germany, Italy, Poland, and Spain), and Australia's Therapeutic Goods Administration. The primary endpoint in the INVINCIBLE-3 Study is overall survival. In March...

Eight Swiss sites are activated in the INVINCIBLE-4 Study, and several patients have been treated European Medicines Agency Authorization to initiate INVINCIBLE-4-Study in France SHELTON, Conn., May 13, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, announces first quarter 2025 financial results and provides a corporate update. Corporate Update INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care ("SOC") treatment in patients with early-stage, operable triple-negative breast cancer ("TNBC") and SOC alone. The primary endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. The INVINCIBLE-4 Study is recruiting patients in Switzerland and is expected to enroll 54 patients across Switzerland and France. In April 2025, the Company and The Swiss Group for Clinical Cancer Research SAKK, a decentralized academic research institute that has been conducting clinical trials of cancer treatments in all major Swiss hospitals since 1965, announced that the European Medicines Agency has authorized the initiation of the INVINCIBLE-4 Study in France in collaboration with Unicancer. The Unicancer French breast intergroup (UCBG) is the French referent cooperative group in breast cancer. The French National Cancer Institute (INCa) accredited the group in 2013, thus acknowledging its academic excellence and operational capability. Since its creation, the group has conducted more than 40 national and international multicenter clinical trials, as well as various translational research projects. INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second and third line treatment for certain soft tissue sarcoma subtypes. The INVINCIBLE-3 Study is expected to enroll 333 patients and initiate sites in eight countries. This study has been authorized by the US FDA, Health Canada, the European Medicines Authority (for France, Germany, Italy, Poland and Spain), a...

32 sites are currently contracted in the INVINCIBLE-3 Study, and 25 patients have been screened Eight Swiss sites are activated in the INVINCIBLE-4 Study, and several patients have been screened Final sarcoma data from our first metastatic study and our INVINCIBLE-3 Study design was presented at the annual Connective Tissue Oncology Society Meeting in November 2024 Final data from our first neoadjuvant breast cancer study and our INVINCIBLE-4 Study design was presented at the annual San Antonio Breast Cancer Society Meeting in December 2024 SHELTON, Conn., March 13, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, announces 2024 year-end financial results and provides a corporate update. Corporate Update INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the standard of care ("SOC") drugs in second and third line treatment for certain soft tissue sarcoma subtypes. The INVINCIBLE-3 Study is expected to enroll 333 patients and initiate sites in eight countries. This study has been authorized by the US FDA, Health Canada, the European Medicines Authority (for France, Germany, Italy, Poland and Spain), and Australia's Therapeutics Goods Administration. The primary endpoint in the INVINCIBLE-3 Study is overall survival. In July 2024, the Company initiated and dosed its first patient in the INVINCIBLE-3 Study. The trial is actively enrolling patients across the US, Canada, Europe and Australia. Up to 60 sarcoma-focused institutions are expected to participate from these regions. The Company has contracted 32 sites with 25 patients screened to date. The Company expects to complete enrollment in the first half of 2026. INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the SOC treatment in patients with early-stage, operable triple-negative breast cancer ("TNBC") and SOC alone. The primary endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. The INVINCIBLE-4 Study is expec...