• In January 2022, PolarityTE was advised by the U.S. Food and Drug Administration (FDA) that it could conduct human clinical trials under PolarityTE’s investigational new drug application (IND) for SkinTE. In May 2022, the FDA granted PolarityTE’s request for SkinTE to be designated as a Regenerative Medicine Advanced Therapy (RMAT). As a result of the RMAT designation the Company was able to engage in an expedited dialogue with the FDA on the tasks that are likely to be necessary to support a Biologics License Application (BLA) for SkinTE. Based on that dialogue the Company plans to run a second multi-center, randomized controlled trial under its current IND to support approval of a broad diabetic foot ulcers (DFUs) indication for SkinTE in a BLA, and the Company plans to follow-up with the FDA regarding the design and implementation of the second clinical trial. The Company believes this strategy will be the fastest and least costly approach to achieving its first BLA submission for SkinTE, with DFUs representing the largest market opportunity within the category of chronic cutaneous ulcers. The Company plans to further engage with the FDA to fully define its development plan for other wound indications.
• In May 2022, PolarityTE began enrollment in its Phase III randomized controlled trial (RCT), which is a pivotal study under its open IND. The RCT will enroll up to 100 subjects at up to 20 clinical sites in the United States. Subjects will be randomized to one of two treatment groups, receiving either SkinTE plus the standard of care (SOC) or the SOC alone. The primary endpoint is the incidence of DFUs closed at 24 weeks. Secondary endpoints include percent area reduction (PAR) at 4, 8, 12, 16 and 24 weeks; improved quality of life, including social isolation, depression, odor, improved function, ambulation, and return to activities based on changes in wound quality of life; and new onset infection of the DFU requiring treatment with topical and/or systemic antibiotics. The Company estimates that it may be able to complete enrollment of 100 subjects by the end of calendar year 2023.
• At the end of April 2022, the Company sold its preclinical research services business operated under its subsidiary, IBEX Preclinical Research, Inc. (“IBEX”), and related real estate assets, and the Company received a promissory note in the principal amount of $0.4 million for the IBEX business and net cash proceeds of $2.3 million from the sale of the real property associated with that business.
• The Company had cash and cash equivalents of $20.5 million and working capital of $19.4 million at June 30, 2022.

Richard Hague, Chief Executive Officer, commented, “The RMAT designation we achieved has already benefited us by expediting direct communication with the FDA, which has provided important guidance on the milestones we need to achieve to efficiently advance our development program for SkinTE in the DFU indication, and what additional work we may need to do to for SkinTE to be approved for other indications.  This will allow us to prioritize our efforts to advance SkinTE and effectively manage our capital and resources accordingly.”

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