aibioNasdaq closes Creative Medical Technology clawback policy compliance matter
Tickers CELZ
Nasdaq said the company had not adopted or disclosed a required clawback policy on time, but is now in compliance and the matter is closed.
Key facts
- Company
- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ)
- News type
- Listings
- Primary source
- Creative Medical Technology Holdings, Inc. 8-K (2025-04-11)
Creative Medical Technology Holdings, Inc. (Nasdaq: CELZ) said in a Form 8-K filed April 11, 2025 that Nasdaq has closed a compliance matter over the timing of its clawback policy. The company adopted the policy on April 4, 2025, under Nasdaq Listing Rule 5608(b)(1), and filed it as an exhibit to an amended annual report on Form 10-K. The 8-K does not say when that amended report was filed.
The policy has retroactive effect to December 1, 2023. The company says it will have no effect on pay already made, because its executive officers have not received any incentive compensation that could be subject to clawback under the policy. That is the company's own statement, and the 8-K does not give the officers' compensation.
What Nasdaq said
Nasdaq wrote to the company on April 8, 2025. The letter said the company failed to adopt the policy on time, as Rule 5608(b)(1) requires. It also said the company did not disclose the policy in its Form 10-K for the fiscal years ended December 31, 2023 or December 31, 2024, before those reports were amended. For that reason the company "previously did not comply" with Rule 5608(b)(2), a separate disclosure requirement.
The same letter says the company is now in compliance with Nasdaq's listing rules, and that the matter is closed.
What the company does
Creative Medical Technology Holdings describes itself in its 10-K as a commercial stage biotechnology company working in immunotherapy, endocrinology, urology, neurology and orthopedics. Its roots are in a patent it acquired in February 2016 for the treatment of erectile dysfunction, held through its subsidiary Creative Medical Technologies, Inc. The company later expanded into re-programmed stem cells for neurologic disorders, lower back pain, Type-1 diabetes, and heart, liver and kidney disease, through subsidiaries named ImmCelz, Inc., StemSpine, Inc. and AlloCelz LLC.
The 10-K is candid that two of those subsidiaries have not started commercial activity. It says neither ImmCelz Inc. nor AlloCelz LLC has commenced commercial activities. The company's own description therefore calls itself commercial stage while two subsidiaries have not reached that stage.
The programs behind the name
The ImmCelz platform, branded CELZ-100, takes a patient's own immune cells, culture them outside the body with cell-free factors, and returns them to the patient. The company says this makes the cells regenerative, and it cites third-party studies run on selected human donor cells. The 10-K describes the process as making the cells "significantly smaller" than stem cells, and says that lets them penetrate damaged tissue more effectively. Those are the company's own claims, resting on the third-party studies it cites.
The company also reports an iPSC cell line developed by Greenstone Biosciences Inc. under a June 2022 agreement, and a proprietary allogeneic line, AlloStem Clinical Cell Line, or CELZ-200, announced in October 2022. The 10-K says that line supports programs including OvaStem for premature ovarian failure, Type I diabetes, and AlloStemSpine for chronic lower back pain.
The clearest regulatory step in the 10-K is for CELZ-201, the CREATE-1 study in Type I diabetes. The FDA cleared the investigational new drug application in November 2022, which allows a Phase I/II trial. The 10-K says patient recruitment started in September 2023. The 10-K also describes a Phase I/II trial of AlloStemSpine in chronic lower back pain, cleared by the FDA in September 2023, which is to enroll 30 people. In February 2023 the company reported what it calls positive three-year follow-up data from its StemSpine pilot study, and the business text gives no sample size for that study. In March 2024 the FDA granted orphan drug designation for ImmCelz in Brittle Type 1 diabetes, a designation that is not evidence of benefit.
What remains unknown
The 8-K is a notice about a policy, and it says nothing about the company's cash, losses or financing. Neither the 8-K nor the business section gives those figures, so a reader cannot judge from these documents how long the company can fund a Phase I/II trial, or how much of the work is paid for by sales. The Nasdaq matter is a closed item, while the programs it describes are still early.