Intensity Therapeutics regains Nasdaq stockholders' equity compliance

Intensity Therapeutics, Inc. (Nasdaq: INTS) said it received a letter from The Nasdaq Stock Market LLC on August 8, 2025 stating that it complies with Nasdaq's stockholders' equity requirement of $2,500,000. Nasdaq's Listing Qualifications Staff had sent a deficiency notice on May 19, 2025, based on the company's quarterly report for the three months ended March 31, 2025.

The rule, Nasdaq Listing Rule 5550(b)(1), applies to companies on The Nasdaq Capital Market with a market value of listed securities below $35,000,000 and annual net income below $500,000. Those companies must keep stockholders' equity of at least $2,500,000. The 8-K defines stockholders' equity as assets minus liabilities.

How the company got there

Intensity raised approximately $6.6 million in July 2025 by selling common stock under its at-the-market offering, or ATM. Its quarterly report for the quarter ended June 30, 2025, filed August 7, 2025, said that, based on cash and cash equivalents at June 30, 2025 plus the July ATM proceeds, the company believes it has at least $2,500,000 in stockholders' equity. Nasdaq's August 8 letter relied on that quarterly report.

The finding therefore depends in part on shares sold after the quarter closed. The 8-K does not give the June 30, 2025 cash balance or the stockholders' equity figure, so the size of the cushion cannot be read from the filing. The letter also warned that if the company does not evidence compliance at the time of its next periodic report, it may be subject to delisting. In that case, Nasdaq staff would send written notice, and the company could appeal to a Hearings Panel.

A change to shareholder meetings

In the same 8-K, the company said its board adopted an amendment to the bylaws on August 12, 2025, effective that day. The amendment sets the quorum for stockholder meetings at one-third of the voting power of the stock outstanding and entitled to vote, present or represented by proxy. Before the change, a majority was required. The filing does not say why the board made the change.

The business behind the listing

Intensity describes itself as a late-stage clinical biotechnology company based in Shelton, Connecticut. Its lead product candidate, INT230-6, combines two generic chemotherapy drugs, cisplatin and vinblastine sulfate, with an amphiphilic molecule called SHAO. It is injected directly into tumors, where the SHAO component lets the two drugs disperse and diffuse into cancer cells. The company notes that cisplatin was first approved in 1978 and vinblastine in 1965, both as intravenous drugs for several cancers.

The first trial, the Phase 1/2 IT-01 study, enrolled 110 patients in three arms: INT230-6 alone, with Merck's Keytruda and with Bristol Myers Squibb's Yervoy. Enrollment was completed in June 2022, and the clinical study report was finalized in September 2023. The Phase 2 INVINCIBLE-2 study in early-stage breast cancer enrolled 91 subjects. Its key endpoints were how much of a tumor died before surgery and whether the drug drew an immune response. The company reports that some patients had more than 95% necrosis, and says the drug had a favorable safety profile.

The Phase 3 INVINCIBLE-3 study began dosing in July 2024. It is an open-label, randomized trial of INT230-6 alone against standard drugs in second- and third-line soft tissue sarcoma. The company plans 333 patients at up to 60 centers in eight countries, with overall survival as the endpoint. The annual report expected enrollment to finish in the first half of 2026.

What comes next

The next test is the company's next periodic report. If it does not show stockholders' equity of at least $2,500,000, the company may be subject to delisting. The 8-K gives no date for the Phase 3 readout or for any further financing. The only trial dates here come from the annual report.

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