PolarityTE, Inc.

Good day and welcome to the Polarity TE third quarter 2021 earnings conference call. Today's conference is being recorded. At this time, I will turn the conference over to Mr. Cameron Hoyler. Please go ahead, sir.

Thank you, operator. Good morning, and thank you for joining Polarity TE's call to discuss third quarter 2021 results. I'm Cameron Hoyler, general counsel. On the call today are Richard Haig, chief executive officer and president, and Jake Patterson, chief financial officer. 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, which are described in our annual report on Form 10-K for the year ended December 31st, 2020, and subsequent reports filed with the SEC. Any forward-looking statements made on this call speak only as of today's date, Wednesday, November 10th, 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 Richard Hague, CEO.

Thank you, Cameron, and good morning and welcome, everyone. I will kick off today's call with an update on our progress related to our IND for Skin TE, as well as share other highlights from the quarter, then turn the call over to Jake Patterson, who will provide a financial update. As you are all aware, we submitted an IND for skin TE with a proposed indication for chronic continuous ulcers on July 23rd and ultimately received a notice of clinical hold from FDA on September 17th. The primary hold issues are certain chemistry, manufacturing and control or CMC items. And the company is implementing what it believes is a well-defined plan to address the issues identified by FDA. we are working diligently to generate and assemble the information required to finalize our complete response, which we expect to submit to the agency by year end. We feel confident that all the hold issues are addressable. However, we did request and we're very pleased to receive additional input from FDA specific to a proposed approach to a new potency assay. Based on this feedback, we believe that the assay strategy we are pursuing could be key to supporting the acceptance of our IND. It's important to remind everyone that to date, FDA has not expressed any concerns regarding the safety of skin TE throughout the IND review process. Additionally, because we came to an agreement with FDA regarding our proposed clinical trial design, we have been able to work in parallel to engage multiple clinical trial sites and believe if our IND is accepted that we can begin enrolling patients shortly after approval. I would now like to discuss other key accomplishments that have recently occurred. On October 26th, the US Patent and Trademark Office issued a Notice of Allowance which covers additional methods using our Minimally Polarized Functional Unit or NPFU technology. This is Polarity TE's third patent allowance in the United States. We were also granted a Chinese patent on September 3rd, a Philippines patent on August 26th, and received notification prior to acceptance for an Israeli patent application on July 25th, each of which covered Polarity TE's NPFU technology. We continue to pursue additional patent applications in the U.S. and abroad related to our regenerative technologies, including Skin TE. Cash used in operations for three months ending September 30 was $4.6 million, or an average of $1.5 million per month, representing a 32% reduction from the comparable period in 2020. An operating loss for the nine months ending September 30 was $24.2 million, a decrease of 35% from the operating loss of $37.4 million for the comparable period in 2020. I'd now like to turn the call over to our CFO, Jake Patterson. Jake?