PolarityTE Secures $22.5 Million Financing to Advance SkinTE Phase III Pivotal Study in Diabetic Foot Ulcers

SALT LAKE CITY, May 20, 2024 (GLOBE NEWSWIRE) — PolarityTE, a clinical-stage biotechnology company developing regenerative tissue products, today announced that it has raised $12.5 million in equity financing from institutional investors and current shareholders. In addition, the Company closed on a new senior secured credit facility with the Avenue Venture Opportunities Fund, L.P. (“Avenue Venture Debt Fund” or “Avenue”), part of Avenue Capital Group. The credit agreement provides up to $10 million in total term loan capital including a first tranche of $5 million funded at closing. Proceeds will be used to advance SkinTE’s Phase III Pivotal Study evaluating SkinTE in the treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II).

“We are very excited to secure this financing and partner with Avenue Capital, a well-known institutional investor, as we continue to advance our Phase III trial,” said John Stetson, CEO of PolarityTE. “This financing strengthens our balance sheet and provides sufficient capital to reach key data readouts on our current trial.”

COVER DFUS II will enroll up to 120 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 12 weeks.  To date, the trial has enrolled approximately 20% of its target population, keeping the company on track to achieve its anticipated enrollment goals and an interim readout in Q1 2025.

About PolarityTE
PolarityTE, headquartered in Salt Lake City, Utah, is a biotechnology company developing regenerative tissue products. PolarityTE’s first regenerative tissue product is SkinTE®. PolarityTE has an open investigational new drug application (IND) for SkinTE® with the U.S. Food and Drug Administration (FDA) and is now pursuing the first of two pivotal studies on SkinTE® needed to support a biologics license application (BLA) for a chronic cutaneous ulcer indication. SkinTE® is available for investigational use only. Learn more at www.PolarityTE.com.

About Avenue Venture Opportunities
The Avenue Venture Debt Fund seeks to provide creative financing solutions to high-growth, venture capital-backed technology and life science companies. The Avenue Venture Debt Opportunities Fund focuses generally on companies within the underserved segment of the market created by the widening financing gap between commercial banks and larger debt funds. The Avenue Venture Debt fund is part of the larger group of funds of Avenue Capital Group. For additional information on Avenue Capital Group, which is a global investment firm with assets under management of approximately $12 billion, visit www.avenuecapital.com.

Parker Scott
IR@polarityTE.com
801-455-1440