Intensity Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
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 2025, new patient enrollment and site activations were paused due to funding issues; however, patients who were already enrolled continue to be dosed, followed and monitored.
Capital Raises and Cash Runway: Since the beginning of the second quarter of 2025, the Company has raised an aggregate of $11.3 million, with net proceeds of approximately $10.1 million in two public offerings and At-the Market offerings (the "ATM"), and has extended its cash runway into the second half of 2026.
In April 2025, the Company entered into a Securities Purchase Agreement with certain institutional investors participating in a public offering and raised an aggregate of $2.35 million, with net proceeds after deducting the fees and expenses of approximately $1.9 million.
In June 2025, the Company entered into an Underwriting Agreement with ThinkEquity LLC in a public offering and raised an aggregate of $2.3 million, with net proceeds after deducting the fees and expenses of approximately $1.8 million.
In July 2025, the Company raised an aggregate of $6.6 million via its ATM, with net proceeds after deducting the fees and expenses of approximately $6.3 million.
"In a challenging financial market, we were able to raise capital and lower our burn rate during the second quarter to continue to treat patients in our two studies, and in July 2025, high liquidity in our stock allowed us to raise additional gross proceeds of $6.6 million at a lower incremental cost. This new capital extends our operating runway considerably, with the remaining capacity under the ATM facility to be used selectively and strategically. Given the capital raised to date, we also believe that we are now compliant with Nasdaq's minimum stockholders' equity listing requirements, pending Nasdaq's confirmation," stated Lewis H. Bender, Intensity Founder, President, and CEO. "In the INVINCIBLE-4 Study, scan images indicate a substantial decrease in tumor activity following two doses of our drug as patients begin their immune-chemo regimen. Based on our prior studies, we believe this effect should be beneficial in increasing the pathological response rate in the cohort of patients receiving our drug and expect to obtain pathology data in 2H of 2026. Lastly, as always, the Company is driven by a focus on patients. This quarter, we strengthen that commitment by forming a collaboration with the author, model, executive producer, speaker, and breast cancer survivor Christine Handy to raise patient awareness of new treatment options on the horizon for patients with early-stage disease."
Second Quarter 2025 Financial Results
Research and development expenses were $1.5 million for the three months ended June 30, 2025, compared to $3.6 million for the same period in 2024. Clinical trial expenses decreased $1.5 million primarily due to lower INVINCIBLE-3 Study costs. In March 2025, the Company paused new site activations and patient enrollments in the INVINCIBLE-3 Study, due to funding constraints. Prior to this pause, the trial had enrolled 23 patients. The Company will continue to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause, and once sufficient funding is obtained, the Company plans to restart site activations and patient enrollment.
General and administrative expenses were $1.2 million for the three months ended June 30, 2025, compared to $1.5 million for the same period in 2024. Insurance expense decreased due to the favorable directors and officers insurance renewal terms compared to the prior policy year, and legal and other expenses decreased as a result of cost saving from the integration of new systems in the administrative areas.
Overall, net loss was $2.5 million for the three months ended June 30, 2025, compared to a net loss of $5.0 million for the three months ended June 30, 2024.
As of June 30, 2025, cash and cash equivalents totaled $2.2 million.
About INT230-6
INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. ...
