PTE - PTE STOCK NEWS

PolarityTE (Nasdaq: PTE) reported a significant financial update for Q3 2021, highlighting a 67% decline in net revenues compared to Q3 2020, primarily due to the cessation of SkinTE sales. Operating loss improved 14% year-over-year, at $7.2 million, while net loss decreased 86% to $1.0 million. The company has $27.4 million in cash, expected to sustain operations into Q4 2022. Although a pivotal study for SkinTE is anticipated post-FDA submission, the decline in revenues from services and products raises concern for investors.

PolarityTE, Inc. (Nasdaq: PTE) will announce its financial results for Q3 2021 on November 10, 2021, at approximately 7:00 a.m. Eastern Time. A conference call will follow at 8:30 a.m. Eastern Time, accessible by phone or via webcast. The company focuses on developing regenerative tissue products, utilizing patients' own tissues for healing. This innovative approach aims to enhance regenerative healing but is in the development stage and has not received regulatory approval for clinical use.

PolarityTE, Inc. (Nasdaq: PTE) announced an update on its Investigational New Drug Application (IND) for SkinTE® aimed at treating chronic cutaneous ulcers. The FDA issued a clinical hold letter, highlighting Chemistry, Manufacturing, and Control (CMC) issues that need resolution before proceeding with a pivotal study. The company is preparing a response and has engaged informally with the FDA for guidance on potency assays. CEO Richard Hague expressed commitment to resolving the hold quickly to advance SkinTE's regulatory process.

PolarityTE, Inc. (Nasdaq: PTE) announced participation in the H.C. Wainwright 23rd Annual Global Investment Conference on September 13, 2021 and the Cantor Virtual Global Healthcare Conference on September 28, 2021. A live audio webcast for both events will be available on their website. PolarityTE focuses on regenerative tissue products, manufacturing from the patient's own tissue to promote healing. Their innovative methods are designed to enhance tissue regeneration but products remain in development and are not yet approved for clinical use.

PolarityTE has appointed Richard Hague as CEO, marking a strategic leadership shift towards clinical research and development. David Seaburg rejoins the Board after a significant management tenure, while Ryan Mathis is promoted to Chief Medical Officer. Hague brings extensive biotech experience, notably in navigating FDA pathways. Under Seaburg, the company achieved substantial cost reductions and revenue growth for its SkinTE product. This management transition is expected to enhance operational focus and propel SkinTE towards a Biologics License Application.

PolarityTE, Inc. (Nasdaq: PTE) announced an update regarding its Investigational New Drug Application (IND) for SkinTE^® targeting chronic cutaneous ulcers. The U.S. FDA indicated that certain Chemistry, Manufacturing, and Control (CMC) issues must be resolved before proceeding with the pivotal study, thus placing the study on clinical hold. The FDA will communicate the details by September 21, 2021. The company is confident in resolving these CMC issues to proceed with clinical trials once addressed.

PolarityTE, Inc. (Nasdaq: PTE) reported its second-quarter financial results for 2021, showing total revenues of $2.54 million, a decline from $4.71 million in Q1:21. SkinTE revenues dropped to $1.20 million from $1.73 million. The company transitioned to a clinical stage with the submission of an IND for SkinTE to treat chronic cutaneous ulcers on July 23, 2021. Cash used in operations decreased to $4.1 million. The company had $32.6 million in cash as of June 30, 2021, which is expected to fund operations into Q3 2022.

PolarityTE, Inc. (Nasdaq: PTE) plans to announce its financial results for the quarter ending June 30, 2021, on August 12, 2021, at approximately 4:00 p.m. Eastern Time. Following the earnings release, a conference call will be held at 4:30 p.m. Eastern Time, accessible via phone and webcast. PolarityTE focuses on developing regenerative tissue products from patients' own tissues, aiming to enhance healing through innovative methods. Their products, including SkinTE, are still in the development phase and are not yet approved for clinical use.

PolarityTE, Inc. (Nasdaq: PTE) revealed final results from a trial assessing SkinTE® for treating Diabetic Foot Ulcers (DFU). The study achieved its primary endpoint with 70% closure at 12 weeks for SkinTE plus standard of care (SOC), compared to 34% for SOC alone (p=0.00032). Additionally, patients using SkinTE showed a significant Percent Area Reduction across multiple weeks (p=0.009). While the trial demonstrated strong efficacy, it will not be part of a Biologic License Application. PolarityTE also announced plans for further trials.