PolarityTE, Inc.

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

Thank you, operator. Good morning, and thank you for joining Polarity TE's call to discuss fiscal year 2021 results. I'm Cameron Hoyler, General Counsel. On the call today are members of the executive team, which includes 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 that are described in our annual report on Form 10-K for the year ended December 31, 2021 and subsequent reports filed with the SEC. Any forward-looking statements made on this call speak only as of today's date, Wednesday, March 30, 2022. 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'll kick off today's call with an update on our progress related to our IND for SPIN-TE, as well as share other highlights from the quarter then turn the call over to Jake Patterson, who will provide a financial update. Clearly, our most critical accomplishment was receiving approval from FDA for our IND to evaluate skin TE for the treatment of chronic cutaneous ulcers in mid-January. Since that approval, we have been working diligently to prepare for the launch of our first pivotal study under IND, a multicenter randomized controlled trial evaluating skin TE in the treatment of Wagner 2 diabetic foot ulcers entitled, Closure Obtained with Vascularized Epithelial Regeneration for DFUs with Skin-TE or COVR DFUs. I am very pleased to report that as of last week, we green-lighted several clinical trial sites to begin identifying patients for enrollment. And as a result, our first patient was consented on Monday. We are targeting up to 20 trial sites for the study and are on track to have approximately 16 sites fully operational by the end of May. As a reminder, this is a 100-patient study with 24-week follow-up and a planned interim data readout targeted for Q3 of next year. For those of you that have followed our story closely, you are well aware that we have a great deal of positive outcomes with SkinTE treating many types of hard-to-treat chronic continuous ulcers while registered as a 361-HCTP product. This includes outcome data from our prior DFU and BLU RCT studies that commenced during the 361 marketing period. Both studies showed statistical significance versus standard of care at 12 weeks for complete mean closure and percent area reduction, with the vast majority of patients needing only one application of SkinTE. As we've discussed previously, it is this data that gives us a great deal of confidence in our ability to successfully execute on our upcoming pivotal trials. Jake will provide more detail in a moment, but I wanted to highlight that we very recently raised $5 million in gross proceeds through a registered direct offering. That offering was intended to both to provide us with additional balance sheet strength and is also expected to help us achieve the reverse stock split that is on our proxy for the special meeting of stockholders that will be held in May. Additionally, we continue to see solid execution in terms of fiscal discipline. The $22.6 million or $1.9 million per month of cash used in operations during the 12 months ended December 31, 2021, compared to $37.8 million or an average of $3.2 million per month during the prior year. I'd now like to turn the call over to our CFO, Jake Patterson. Jake?