PolarityTE Reports First Quarter 2022 Financial Results and Provides Business Update

May 16, 2022

SALT LAKE CITY, May 16, 2022 /PRNewswire/ — PolarityTE, Inc. (Nasdaq: PTE) a biotechnology company developing regenerative tissue products and biomaterials, today provided a business update and reported financial results for the three-month period ended March 31, 2022.

• Thus U.S. Food and Drug Administration (FDA) granted PolarityTE’s request for SkinTE to be designated as a Regenerative Medicine Advanced Therapy (RMAT). As noted in a press release issued on May 13^th, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising regenerative medicine products intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, where preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for such disease or condition. As a result of the RMAT designation grant, PolarityTE plans to coordinate with the FDA a multidisciplinary, comprehensive discussion regarding the SkinTE development program, including planned clinical trials and plans for expediting the manufacturing development strategy.
• PolarityTE announced on May 3^rd that the first subject has been enrolled in its Phase III randomized controlled trial (RCT), which is a pivotal study under the Company’s open IND, and since that announcement additional subjects have been screened and enrolled. The RCT is entitled “Closure Obtained with Vascularized Epithelial Regeneration for DFUs with SkinTE,” or “COVER DFUs.” COVER DFUs 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 has received additional patent issuances and allowances, and the total number of allowed and granted utility patents worldwide is now 18, 4 in the United States and 14 internationally. The Company continues to pursue additional patent applications in the United States and abroad related to its regenerative technologies, including SkinTE®.
  • The USPTO notified the Company that U.S. patent application no. 17/326,734 will issue on May 24, 2022, as U.S. Patent No. 11,338,060. The claims to be issued are for compositions that relate to the Company’s minimally polarized functional unit (MPFU) technology in combination with a cryoprotectant.
  • The Company is also pleased to announce that the Costa Rican Patent Office (CRPTO) has issued a notification of issuance for patent application no. 2017-0296. Israeli patent application No. 252613 also granted on March 2, 2022, as Israeli Patent No. 252613. The application in Costa Rica and the patent in Israel also relate to the Company’s MPFU technology. New Zealand patent application no. 755260 was granted on March 25, 2022, as New Zealand Patent No. 755260. This patent in New Zealand relates to the Company’s MPFU technology. Additionally, the Company received a notice of allowance for Vietnamese patent application no. 1-2017-02498, also relating to the Company’s MPFU technology.
• At the end of April 2022, we sold our preclinical research services business operated under our subsidiary, IBEX Preclinical Research, Inc., and related real estate assets, and we received a promissory note in the principal amount of $400,000 for the IBEX Preclinical Research business and net cash proceeds of $2.6 million from sale of the real property associated with that business.
• Cash used in operations for the three months ended March 31, 2022, was $6.0 million, or an average of $2.0 million per month, representing a 9% reduction from the comparable period in 2021.
• The Company had cash and cash equivalents of $18.7 million and working capital of $17.2 million at March 31, 2022.

Richard Hague, Chief Executive Officer, commented, “We are very excited to be underway and enrolling patients in COVER DFUs, and I am very proud of our team for accomplishing that milestone so effectively after we announced our transition for SkinTE from a 361 HCT/P to a 351 HCT/P last year.  FDA designating SkinTE as an RMAT enhances this milestone, and we believe the RMAT designation will help us advance our development program, efficiently.  We continue to focus on being disciplined with our finances and were pleased to complete the divestiture of our Ibex Preclinical Research business as we complete our transition to a clinical-stage company advancing our key asset, SkinTE—now with the benefit of an approved IND, actively-enrolling Phase III pivotal study, and RMAT designation.”

Read the Full Report Here »