Intensity Therapeutics gets Nasdaq stockholders' equity deficiency notice

Intensity Therapeutics, Inc. (Nasdaq: INTS) received a letter on May 19, 2025 from the Listing Qualifications Department of The Nasdaq Stock Market LLC saying it does not meet the minimum stockholders' equity requirement for continued listing on The Nasdaq Capital Market. The company disclosed the letter under Item 3.01 of a Form 8-K filed May 20, 2025. The letter is based on the company's Quarterly Report on Form 10-Q for the three months ended March 31, 2025.

The requirement

Nasdaq Listing Rule 5550(b)(1) requires companies on the Capital Market with listed securities worth less than $35,000,000 and annual net income below $500,000 to keep stockholders' equity of at least $2,500,000. The 8-K does not state the company's stockholders' equity figure or its market value of listed securities.

The deadline and what follows

Under Nasdaq rules, the company was given 45 calendar days, or until July 3, 2025, to submit a plan to regain compliance. The filing calls this the Compliance Plan. If the Staff finds the plan acceptable, it has discretion to grant an extension of 180 calendar days from the date of the notice. The 8-K says there can be no assurance the plan will be accepted or that the company will regain compliance.

If the Staff does not accept the plan, it will say so in writing and the common stock will be subject to delisting. The company could then appeal to a Nasdaq Hearing Panel. The notice has no immediate effect on continued listing, subject to the company's compliance with other listing requirements. The 8-K does not describe what the Compliance Plan contains.

Chief Executive Officer Lewis H. Bender signed the 8-K, dated May 20, 2025.

About the company

Intensity describes itself in its annual report for 2024 as a late-stage clinical biotechnology company working on localized cancer reduction that leads to anti-cancer immune activation. Its approach is direct injection into tumors of a product made from its DfuseRx discovery platform.

The lead candidate, INT230-6, is made of cisplatin and vinblastine sulfate, both proven anti-cancer cytotoxic agents, combined with an amphiphilic agent. The annual report describes the Phase 2 INVINCIBLE-2 study in early-stage breast cancer as enrolling 91 subjects. It says the company first dosed a patient in the Phase 3 INVINCIBLE-3 study, in soft tissue sarcoma, in July 2024.

The money

The annual report shows cash and cash equivalents of $2,590 thousand at December 31, 2024, against $8,556 thousand a year earlier. Cash used in operating activities was $15.2 million in 2024. The net loss was $16.3 million, up from $10.5 million in 2023, and the accumulated deficit was approximately $66.8 million at year-end 2024.

The report of the company's independent registered public accounting firm for 2024 contains a statement of substantial doubt about its ability to continue as a going concern, because of recurring losses from operations and negative cash flows. The annual report also says the company expects significant expenses and operating losses for the next several years, including to fund the INVINCIBLE-3 study.

What the notice leaves open

The 8-K says the notice has no immediate effect on the listing. It does not state the company's equity at March 31, 2025 or how the company plans to restore it. It also does not say whether the company has submitted a plan or whether the Staff has accepted one.

For readers, the practical question is whether the company can fund the Phase 3 program while meeting the equity minimum. The 8-K answers neither part of that question. The annual report's cash figure and going-concern language predate the notice, and any later filing will be needed to show whether the plan worked.

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