PolarityTE, Inc.

Good day and welcome to the Polarity TE second quarter 2021 earnings call. Today's conference is being recorded. At this time, I would like to turn the conference over to Rich Hurley, Vice President of Investor Relations. Please go ahead, sir.

Thank you, operator. Good afternoon, and thank you for joining Polarity TE's call to discuss second quarter 2021 results. I'm Rich Hurley, Vice President of Investor Relations. On the call today are members of the executive team, which includes David Seberg, CEO, Richard Haig, President and COO, and Jake Patterson, Interim CFO. Before we begin, I would like to remind everyone that today's discussion will include statements about the company's future expectations, plans, and prospects that constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. We caution that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated. These forward-looking statements are based on our current expectations and may differ materially from actual results due to a variety of factors, including but not limited to those detailed under the caption risk factors that are described in our annual report on Form 10-K for the year ended December 31, 2020, and subsequent reports filed with the SEC. Any forward-looking statements made on this call speak only as of today's date, Thursday, August 12, 2021, and we disclaim any obligation to update such statements to reflect events or circumstances that occur after today's call, except as required by law. I'd like to highlight to participants that the call is being recorded. A replay of the recorded call will be available on our website in the investor relations section shortly following the conclusion of the call. Additionally, it is the property of Polarity TE and any redistribution, retransmission, or rebroadcast of the call in any form without Polarity TE's express written consent is strictly prohibited. I would now like to turn the call over to David Sieberg.

Thank you, Rich, and welcome, everyone. I'd like to kick off today's call with some corporate updates and highlights from our quarter, and then turn the call over to Richard Haag, who will review our development plan for skin TE, followed by a financial update by Jake Patterson. As many of you are aware, on July 23rd, we submitted an IMD for skin TE and chronic continuous ulcers. We propose this indication because chronic continuous ulcers represent an unmet medical need in a large market with significant economic burden. To put this into context, it has been estimated that roughly 1% to 2% of adults in developed countries will experience a chronic contagious ulcer during their lifetime. Additionally, the costs associated with treating chronic wounds are substantial. For example, it has been reported that the average hospital charge per pressure injury is $48,000, and the direct costs of diabetic foot ulcers is on par with cancer at roughly $80 billion per year. Furthermore, based on the learnings from our prior clinical experience of treating over 1,200 patients with skin TE as a 361-HCTP, we chose to pursue an indication that included the most challenging and cost-intensive wounds with limited treatment alternatives. We believe this strategy presents a great opportunity to capture market share and establish optimized pricing and reimbursement. In April of 2020, we announced our plan to pivot SCIN-TE from a 361 HCTP pathway to a 351 pathway and informed investors to expect our IMD to be submitted sometime during the second half of 21. Immediately following that announcement, our entire team began working to ensure that we could submit this near the beginning of our guided range. I want to congratulate our entire team because it was their hard work and dedication and commitment that allowed us to submit our IND to the FDA in July. Now that our IND has been submitted, our top two priorities going forward as a clinically staged company are as follows. First, securing acceptance of our IND and commencing our first pivotal study as we advance skin TE through the regulatory process towards an eventual BLA submission. And second, continued focus on capital efficiency. Jake will provide additional details in his prepared remarks on this side, but I would like to highlight that cash used in operation activities during the second quarter was 38% lower than the prior quarter. Furthermore, we continue to target a base operational cash burn of less than $2 million per month on average. This is an exciting time to work at Polarity TE, and we are very proud of the progress we've made to date. We continue to believe that a successful BLA will make skin T a more valuable asset, and we remain committed to working closely with the FDA to accomplish that outcome. Now I'd like to turn the call over to Richard Hague, who will provide additional detail surrounding the development plan for skin T. Richard?