Q2 2022 PolarityTE Inc Earnings Call
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Good day and welcome to the Polaris T E second quarter, 2022 business updates and financial results Conference call.
Today's conference is being recorded.
This time I would like to turn the conference over to Jacob Patterson Chief Financial Officer. Please go ahead.
Thank you operator, good afternoon, and thank you for joining clarity Tvs call to discuss second quarter 2022 results.
I'm Jacob Patterson Chief Financial Officer.
On the call today are members of the executive team, which includes myself and Richard Hague, Chief Executive Officer and President.
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, including but not limited to.
Statements about our financial resources operations, our <unk> and related clinical trials and I am the use in clinical trials for other skin indications, which 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 Thursday August 11 2022.
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 two 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, p/e and any redistribution retransmission or rebroadcast of the call in any form without <unk> expressed written consent is strictly prohibited.
I would now like to turn the call over to Richard Hague.
Thank you Jay and good afternoon and welcome everyone.
I have three important topics to discuss today.
First is an update on our current phase III cover <unk> trial.
As an update on our recent type B meeting with FDA and third is our plan of operations for advancing the development of <unk>.
Our 100 subject phase III pivotal cover <unk> trial began enrolling in late April with three active sites as of today. We now have 10 subjects enrolled and 11 active sites with a goal of having up to 20 active sites by the end of Q3.
We expect to have the first 50 of the 100 total subjects enrolled by the end of Q1, and 2023 and be in position to read out interim data approximately six months later.
We are targeting full enrollment by year end of 2023 with follow up on all subjects completed by late Q2.
Early in Q3 and 2024.
As a result of the arm that designation, we were able to engage in an expedited dialogue with the FDA on various topics related to the steps needed to support a biologics licensing application or BLA for skin p/e.
Based on that dialogue the company plans to pursue a broad indication for diabetic foot ulcer wound types and we will run a second multicenter randomized controlled trial under its current IMD.
To support the submission of a BLA.
We plan to work closely with FDA regarding the design and implementation of the second clinical trial with.
With the plan to start that trial in early 2023.
Based on the clinical development plan outlined at our approved IMD and the arm that designation granted to <unk> for both <unk> and <unk>.
We had anticipated that we could run a second trial in <unk> in combination with our cover few trials to potentially get a multimodal type indication.
However, FDA would not provide the commitment we felt we needed to support that approach.
After considering fda's feedback, we determined that pursuing a broad indication for all Wagner grade <unk> will be highly advantageous given that these wounds clearly represent the largest market opportunity within the category of chronic cutaneous ulcers and for the fact that there are very limited treatment options for advanced grade <unk>.
<unk>.
This approach should also allow us to use many of our current clinical trial sites.
As a result, it has the potential to be faster and less expensive to complete the <unk> trial considered under our previous plan.
If we are successful in gaining alignment with FDA on our second trial.
We believe that it will be possible to generate the necessary data from both trials, we will offer a BLA submission in the first half of 2025.
Additionally, FDA indicated that data generated from these trials could potentially be leveraged to support an expedited submission pathway or other loan types in the future.
We plan to further engage with FDA to fully define our development plan for other wound indications in the coming months.
Lastly, I would like to briefly share our thoughts related to our plan of operation and corporate strategy.
Because we believe <unk> has the potential to be a game changing treatment for a range of complex hard to heal wounds.
Our objective is to get skin feedback on the market in the most efficient and effective manner possible.
We've been highly encouraged with the amount of recent interest we've received from others in the industry since reporting on the excellent progress. We've made in 2022 with the IND approval the kickoff of our phase III covered trial and the <unk> designation.
While we have been successful raising capital in the past and will continue to seek opportunities to raise capital to fund the development plan for <unk>. It is important to note that we are firmly committed to exploring strategic and synergistic opportunities that would support our business plan and subsequently enhance shareholder value.
I would now like to turn the call over to Jake for financial update.
Jake.
Thank you Richard.
Operating costs and expenses decreased $3 6 million or 35% for the three months period ended June 32022, compared to the three months period ended June 32021.
For the three months period ended June 32022 cash used in operating activities was $8 2 million.
Which includes $2 1 million of professional fees incurred in connection with our pursuit of our strategic trends. So the actions that did not materialize.
$5 million of costs related to our June offering and $6 million of clinical trial related expenses. Excluding these items our base operating cash used in operating activities was $5 million.
Or an average of $1 $7 million per month.
<unk> to $4 $1 million of cash used in operating activities for an average of $1 $4 million per month for the three months period ended June 32021.
As of June 32022, we had two.
We had $25 million in cash and cash equivalents and working capital of approximately $19 4 million.
We believe cash and cash equivalents on our balance sheet will fund our business activities into the first quarter of 2023.
Our goal continues to be maintaining a base operational cash burn, which excludes costs associated with clinical trials and BLA related activities well below $2 million per month on average I'd now like to turn the call back over to Richard for additional operational.
Rich.
Thank you Jake.
In closing I'd like to reiterate how encouraged we are by the progress we've made year to date with the ramp up of our first pivotal trial and with the additional access we have the FDA through the armet designation, we are well positioned to execute on the steps leading to the submission of our first BLA for <unk>.
I'd like to thank the entire <unk> to the dedication and hard work that has allowed us to get to this point I would also like to thank our investors for their continued support of the company.
Operator, I'd now like to open the call for Q&A.
Ladies and gentlemen, if you would like to ask a question. Please signal by pressing star one on your telephone keypad. Please ensure that the mute button on your telephone is switched off to allow your signal to reach our equipment.
Your name before posing a question.
The voice conference phone and limitation on your line is open.
The starwood to ask a question.
Briefly to allow all participants the opportunity to signal for questions.
It appears there are no questions. Therefore that concludes the Polaris ETE second quarter 2022 business update and financial results Conference call. We thank you all for your participation.
Thank you Rob.
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