Spectral Medical Inc.

and welcome to the Spectral Medical Inc. Investor Update presentation and conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Ali Mahdi. Thank you, Ali. You may begin.

Thank you, operator, and good afternoon, everyone, and thank you for joining us today for Spectral Medical's Corporate Update Conference Call. Joining me today are Chris Sito, Chief Executive Officer, Dr. John Kellum, Chief Medical Officer, and Blair McInnis, Chief Financial Officer of Spectral. If you have not seen the news release which was issued earlier today concerning a reminder for this call, please note that an updated presentation has been posted on Spectral's website. which will be used by management during today's call. Following management's presentation, we will conduct a Q&A session. Instructions will be provided at that time for you to join the queue for questions. Before we begin, we are required to provide the following statements regarding forward-looking information, which is made on behalf of Spectral Medical and all of its representatives on this call. Remarks and answers to your questions today may contain forward-looking information about future events or the company's future performance. This information is subject to risks and uncertainties that may cause actual events or results to differ materially. Any information regarding forward-looking statements is made as of the date of this call, and the company does not undertake to update any forward-looking statements. Please read the forward-looking statements and risk factors in the MD&A as these outline the material factors which could cause or would cause actual results to defer. The company will not provide guidance regarding future events during today's call. Management does not anticipate providing guidance in future quarterly or interim communications with investors. I'd like to turn the call over to Chris.

Thank you, Ali, and good afternoon, everyone. Today we're going to take you through a very detailed presentation on our plan to accelerate the pace of Tigris enrollment. First, I cannot underscore enough how well our business is positioned for regulatory and commercial success, but I want to acknowledge the frustration around the pace of Tigris enrollment. And so that's the million dollar question for me, for John, for Blair, for the Spectral team. What are you doing about it? And that is what our presentation today focuses on. How we are going to change the course of Tigris enrollment. So let's begin. Turning to slide five. We have a short recap on Spectral's transformative journey and how we have strengthened this business since the Euphrates trial outcome. We've consistently looked for opportunities to optimize the outcome for our PMX product, both on a clinical front and a commercialization front. In 2019, it was a fresh start for Spectral, with a de-risk Tigris trial design approved by the FDA. We also went through the development of SAMI, and in 2019, the FDA approval for its use in Tigris. This was a defensive measure so as to have a device in place that could run the PMX therapy and thus reduce trial execution hurdles. In 2020, we built the commercial foundation and entered into our exclusive distribution agreement with Baxter. We said back then that Baxter was the perfect commercialization partner, and that couldn't be more true today. In 2021 was a period of blocking and tackling. We brought on Dr. Kellam, a highly regarded clinician, and a leading world expert on sepsis to lead our clinical team. We also looked for ways to continue to optimize enrollment and received approval from the FDA to use SOFA for inclusion criteria, a tool that has resulted in inclusion of a significant number of our randomized TIGRS patients today. In 2022, we went through a period of repositioning. PMX was granted breakthrough device designation by the FDA, Additionally, the FDA approved the increase of an additional 10 sites, allowing for a total of 25 TIGRIS trial sites. We made this move as we recognized we needed more shots on net. And finally, in 2022, we refocused spectral resources on TIGRIS and entered into the iDialco transaction with InfoMed. Which brings us to today. Our plan to move TIGRIS forward focused on two key levers, increasing the number of sites And two, site productivity. Turning to slide six. This is a snapshot of where we are today. As of today, we're at 53 patients randomized, which is just over a third of the way through Tigris. In terms of number of sites open for enrollment, we have 16. We had two recent site additions, Medical University of South Carolina in January and University of California San Francisco in February. And both are very active and we're very pleased with how they're performing so far in the clinical trial. We have a number of trial sites in the pipeline with a path to 25 sites by the end of September of this year. Certainly, there's a question on why do we believe we can bring new sites on at this cadence. Our confidence around this is based on the work that was done in 2022 and that we are in clinical trial agreement phase or CTA phase with these pipeline sites. So basically, when we are at this stage, the site is committed and few, if any, drop out. But John will speak to that in more detail on additional sites and activities taken to build this pipeline later in the presentation. Turning to slide seven, which speaks to the challenges that we have faced in Tigris, but also speaks to the steps being taken to remove or mitigate these challenges. The key challenges that we have faced have resulted in a slower than anticipated enrollment rate. Community rates of sepsis certainly have played a role. as well as the mortality due to COVID of patients, which likely would have been suitable for TIGRIS. Clinical site staffing turnover and burnout continue to be issues in clinical research enterprises facing long recovery as a result of the pandemic. TIGRIS is on the complex side of the scale with respect to clinical trials, and less difficult trials will recover first from an enrollment perspective. Another of the key challenges is public trust and awareness of investigational devices and therapies. This has been an impediment on the informed consent side to enrollment, and this has created a difficult recruiting environment for us. They say misery loves company. We are not the only ICU trial that has struggled with enrollment post-COVID, but these are the cards we have been dealt and we have to find a way. So what are the steps being taken? The first is getting more shots on net, and that has to do with increasing the number of trial sites. The remainder is focused on site productivity. We have increased our trial resources internally. The iDIALCO transaction has allowed us to fully allocate our clinical team's focus on tigris. We have also taken some what we consider extraordinary moves, including transitioning to a new CRO, Beaufort, as well as embarking on a meaningful public and investigator education campaign. All of which John is going to get into deeper into detail later in the presentation. Turning to slide eight, pre-screening data or where are the patients? We've seen pretty robust pre-screening since mid-2022 with aggregate screening averaging anywhere from 50 to 100 patients per week. So in a typical week, we are seeing just over 100 patients with sepsis. and only converting anywhere from 0.5% to 1% of those screened into a randomized patient. This equates to an enrollment rate of approximately 0.18 patients per site per month, which is significantly lower than our assumptions when Tigris was initially launched. However, as a comparison, Euphrates' average enrollment rate was 0.136. So why is this conversion ratio of screened patients to randomization low? Well, We have a strict inclusion criteria combined with a recovering clinical research environment. However, these tight criteria benefit our mortality data and effect size. John, just quickly, can you discuss the waterfall chart on the right and certainly speak to perhaps some of the exclusion criteria buckets where we potentially have an ability to influence and improve site productivity?