Biostem Technologies New

Hello, and thank you for standing by. My name is Regina, and I will be your conference operator today. At this time, I would like to welcome everyone to the BioSTEM Technologies second quarter earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you'd like to ask a question during this time, simply press star, then the number one on your telephone keypad. I would now like to turn the conference over to Adam Holdsworth, Managing Director of Investor Relations, Please go ahead.

Good afternoon, everyone, and thank you for joining our conference call to discuss BioSTEM's second quarter 2024 financial results and corporate highlights. Leading the call today will be Jason Mataszewski, Chief Executive Officer, joined by Mike Fortunato, Chief Financial Officer. Before we begin, I'd like to remind everyone that our remarks today may contain forward-looking statements based on the current expectations of management. which involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including the risks and uncertainties described in the company's filing with the over-the-counter market. You are cautioned not to place any undue reliance on any forward-looking statements, which speak only as the date made and may change at any time in the future. Although we voluntarily do so from time to time, the company undertakes no commitment to update or revise forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by typical securities laws. This also includes references to certain financial measures that are not calculated in accordance with generally accepted accounting principles or GAP. We generally refer to these as non-GAP financial measures. Reconciliations of those non-GAAP financial measures to the most comparable measures calculated and presented in accordance with GAAP are available in the earnings press release on the investor relations section of BioSTEM's website. With that, I'm now pleased to turn the call over to Jason Mataszewski.

Thanks, Adam, and I appreciate you all joining this call. I'm happy to share that BioSTEM has reached a new milestone by achieving a second consecutive record quarter making the highest revenue and profitability reported in our company's history. Our strong financial results reflect the positive momentum we are experiencing across our business, which has been driven by the strong commercial performance of our bioretain allografts across multiple sites of service. These successes significantly contributed to our results and reinforce our commitment to driving continued growth and profitability. First, let's discuss second quarter highlights. And then I'll update you on our progress towards achieving our strategic priorities. For the second quarter, revenue grew year over year by several orders of magnitude to 74.5 million, setting an all-time record for quarterly revenue. 2024 is trending strongly. With the first half reaching 116.4 million in revenue, a complete 180 from the 1.6 million reported for the same period last year. Our gross margin continues to be strong in the mid-90 percentile, and we strengthened our cash position, ending the quarter with $6.6 million in cash, a healthy increase of $6 million in the quarter. Additionally, BioSIM is making notable achievements with our strategic priorities. In January, we set the bar high to substantiate our bioretain processing technology. We are working diligently to launch multiple clinical trials and publish peer-reviewed papers on our retrospective data accumulated from all of our allografts used on our various wound types. We are committed to completing these studies to proactively address potential updates to the reimbursement landscape. We agree the future coverage requirements for skin substitutes by the MACs will necessitate clinical data to support product efficacy, which we are addressing through these trials and have high confidence our allografts manufactured with our bioretained processing technology will do just that. Some of the work we are doing on retrospective data has demonstrated exceptional results in a wound care study recently published in the industry's leading peer-reviewed journal, Health Science Reports. The study compared the effectiveness of AMIRAP2 processed using our proprietary bioreting technology with a leading competitor's product. The results were overwhelmingly favored for BioSTEM. with AW2 requiring fewer applications and achieving a significantly higher percent error reduction in diabetic foot ulcers compared to the competitor's product. This tremendous validation of the bioretain technology and the clinical utility of our allografts improving wound care outcomes underscores our commitment to innovation and patient care. On the clinical trial front, we have also received IRB approval for the clinical study evaluating Amniorap2 in diabetic foot ulcers. This study aims to demonstrate the efficacy of AW2 in treating DFUs and preventing complications such as lower limb amputations. The primary endpoint of the study is the percentage of subjects whose target ulcer achieved complete wound closure within 12 weeks. Secondary endpoints comparing differences between treatment groups include the time to closure, percentage change in wound area and volume at 12 weeks, total number of applications used to achieve complete wound closure, and time to closure for subjects that cross over. The safety endpoint will evaluate spontaneously reported and elicited adverse events, and the exploratory endpoint will assess the differences between treatment groups and clinical signs and symptoms of infection. We are optimistic that with positive study data, similar to our retrospective paper and data set, these study results will lead to product commercial advancement with expanded payer insurance coverage within the advanced wound care market. Given the substantial economic burden diabetic foot ulcers place on the US healthcare system, where estimated annual treatments can cost up to $13 billion, we are confident that our allografts will deliver a meaningful impact. Our allografts offer significant potential to improve patient outcomes while reducing healthcare costs. Looking ahead, we plan to continue pulling many levers and launch additional clinical studies in 2024 and beyond to further demonstrate the effectiveness of our allografts. These studies will provide valuable insights and reinforce the clinical benefits of our BioRetain method, driving continued innovation in the wound healing segment. Turning to the next steps as a public company, I'm excited to announce that we have made a strategic decision to become a fully reporting entity with the SEC and to uplift to the NASDAQ stock market. We have worked diligently to meet NASDAQ's stringent uplifting requirements and recognize the importance of BioStem trading on a national exchange. for our current and future shareholders as we advance as a high-growth company. Listing on NASDAQ will provide investors with a global trading platform, increased visibility, and liquidity opportunities, particularly for institutional investors worldwide. This process will depend on the successful completion and review of our Form 10 filing with the SEC, as well as the approval of our NASDAQ listing application. This step is crucial to our commitment to financial growth and expanding our presence in the capital market. We strongly believe these strategic finishes will position BioSTEM for continued success and unlock greater value and shareholder opportunities. I thank you for believing in us as we embark on this exhilarating new journey to manufacture products that change lives. With that, I'll hand the call over to Mike for a review of our Q2 2024 financial results.