IsoRay, Inc. Common Stock (DE)

Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the ISO-RAE's Fiscal 3Q 2022 Earnings Call. At this time, all participants are in a listen-only mode. After management's prepared remarks, there will be a question and answer session. I would now like to turn the call over to the host, Mark Levin. Please go ahead.

Thank you, operator. Good afternoon, and thank you for joining us today for the ISO-RAE Fiscal Third Quarter 2022 Earnings Call for the quarter ended March 31st, 2022. Before we get started, I will take a few minutes to read the forward-looking statement. Certain statements in this conference call constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as amended. When used in this conference call, words such as will, believe, expect, anticipate, encourage, and similar expressions as they relate to the company or its management, as well as assumptions made by and information currently available to the company's management, identify forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management's current expectations and beliefs about future events as of today, May 10, 2022. As with any projection or forecast, they are inherently susceptible to uncertainty and changes in circumstances, and the company undertakes no obligation to and expressly disclaims any obligation to update or alter its forward-looking statements, whether resulting from such changes, new information, subsequent events, or otherwise. Additional information concerning forward-looking statements is contained under the headings of safe harbor statement and risk factors listed from time to time in the company's filings with the Securities and Exchange Commission. We will begin today's call with Lori Woods, ISA RACE Chief Executive Officer, and then Jonathan Hunt, ISA RACE Chief Financial Officer, who will discuss the fiscal third quarter 2022 financial results. Following their prepared remarks, we will take questions from our analysts and institutional investors. I will now turn the call over to Lori Woods.

Thank you, Mark. Good afternoon, and thank you for joining us today for ISRA's fiscal third quarter 2022 earnings conference call for the quarter ended March 31st 2022. Following my prepared remarks, our Chief Financial Officer, Jonathan Hunt, will provide a more detailed review of our fiscal third quarter financial results. I am pleased to share with you the continued progress we experienced in our fiscal third quarter. Total revenue for the fiscal third quarter increased 12% versus the year-ago quarter to a record $2.91 million. Trends accelerated throughout the quarter, culminating with both record revenue and procedure volumes for the month of March. I'm encouraged by the steadily increasing sales we have been realizing. The path of the rebound, primarily in our prostate business, has not been as fast as we would have expected. However, the trends in our core prostate business give me incremental confidence that more and more men who have delayed treatment over the past two years are now seeking treatment at an increasing rate. Complementing the ongoing steady rebound in our core prostate business in the March quarter was the continued growth of our brachytherapy treatments for other cancers. Non-prostate revenue and procedures reached records in the March quarter. The growth was driven by increasing consideration and adoption of our proprietary isotope primarily for the treatment of brain, head and neck, and lung cancers. We continue to see strong opportunities to bring cesium's therapeutic benefits to more patients battling critical cancers such as these. Our sense is that the continued adoption of cesium-131 in the treatment of other cancers is going to be fueled by two key components. Certainly, our continued efforts to build awareness of the efficacy of using cesium-131 to address these difficult to treat cancers will continue to play a meaningful role. At the same time, a key driver has been the expansion of compelling data from clinical studies. One such study, which we have been keeping you updated about, is the ongoing Phase I-II trial led by researchers at the University of Cincinnati. You no doubt remember this significant study focuses on the combination of PD-1 inhibition and cesium-131 brachytherapy in patients with recurrent head and neck cancer. The Phase I portion that evaluates the safety of the treatment combination is now complete. The investigators will be following these patients closely, and we hope to move on to the larger phase two part of the trial to start looking at treatment effect later this year. At that time, we anticipate that the study will move to a multi-institutional trial. We're happy to see the interest in using cesium-131 for the treatment of recurrent head and neck cancers with the additions of other prestigious institutions. Given the high recurrence rate in head and neck cancers, the deterioration in quality of life for many patients who have to undergo subsequent surgery and radiation is oftentimes substantial. As was demonstrated in prior prospective studies, cesium-131's targeted approach offers a potential effective radiation treatment regimen, but with fewer side effects, such as radiation-related damage to adjacent healthy tissues and less collateral damage to adjacent critical structures in the head and neck. We're excited about the potential that the combination of cesium-131 brachytherapy with Merck's PD-1 inhibitor Keytruda may demonstrate in this study in terms of safety and possible disease control. We are confident in the promise it holds. and the important contribution it makes in continuing to build awareness of cesium-131 amongst key professional constituencies. We will continue to keep you updated as the study progresses. Another interesting data series was presented last week at the American Association of Neurological Surgeons scientific meeting in Philadelphia. The abstract demonstrated compelling clinical outcomes for recurrent glioblastoma patients treated with gamma-tyl therapy powered by cesium-131. Similar to the head and neck studies, the unique targeted radiation of cesium-131 seeds embedded in the gamma-tyl implants suggests not only the effectiveness of the treatment option, but the enhanced quality of life aspects relative to other radiation regimens, such as external beam radiation therapy. We believe additional studies of the benefits of cesium-131 for the treatments of certain cancers, such as these, will be additional drivers for growth in our non-prostate business. Clinical trials and studies will remain a core part of our growth strategy, and we will continue to invest in these key areas of R&D. We are also continuing with our strategic efforts focused on leveraging opportunities to further brand awareness and to build our leadership position within our key markets and constituencies. This week, we will be attending the American Urologic Association or AUA annual meeting. The AUA meeting is considered the foremost meeting in urology. Being a part of this gathering is critical because the organization provides urologists with information on the latest innovations in urologic medicine. It plays a central role in connecting industry with physicians and creating a partnership aimed at providing urologists the tools to more effectively diagnose and treat urologic diseases. Another high-profile event will see ice array at center stage. This year's American Brachytherapy Society 2022 Annual Conference next month in November is widely anticipated in the brachytherapy community. This will be the first in-person annual meeting in almost two years, and we are excited to have a central part in this year's events. ABS annual meetings are well known for their outstanding attendance and impact on hands-on educational opportunities, interactive sessions with experts, and industry demonstrations of state-of-the-art equipment, software, and services. Widely recognized for the value it provides oncologists practicing in this field of medicine, a central role of this prestigious event is meaningful. As a sponsor, Isolary will be hosting a lunch symposia on the benefits of MRI-assisted radiosurgery for the treatment of prostate cancer. The lecture is entitled, Eliminate Uncertainty, Increase Precision, and Reduce Toxicity, MRI-Assisted Radiosurgery, or MARS. The MD Anderson Technique Using Cesium-131. Dr. Stephen J. Frank, MD, Radiation Oncologist at MD Anderson Cancer Center and inventor of the C4 serious marker, will be presenting. As described by Dr. Frank, MRI-assisted radiosurgery is the next generation of brachytherapy by utilizing MRI at every step of the quality assurance process to improve clinical outcomes. MARS enables treatment planning to the intraprosthetic dominant lesions, reduces exposure to external urethral sphincter, and ensures precise radiation dose delivery. Cesium-131 is the only isotope that is FDA-approved to be used in conjunction with the serious marker. We continue to work to finalize our validations and processes in anticipation of a formal launch later this year. In addition to the luncheon, ISOR-A has two abstracts submitted from the Cesium-131 Advisory Group, or CAG. These abstracts are based on 12 years of experience in cesium-131 implants from each of the CAG physicians who came together to provide recommendations on how best to implant using cesium-131. This knowledge and experience targets new practitioners who can benefit from their cumulative experience and be confident in how they treat their patients using cesium-131. Before I turn the call over to Jonathan, I want to address our isotope supply chain. Recall that we currently source our cesium isotope from two separate reactors, both of which are located in Russia. We have not experienced any disruptions or significant delays to date and continue to have a consistent supply of isotope from these reactors. Of particular importance, cesium-131 is a medical isotope that is not subject to any sanctions. We continue to monitor the situation closely, but do not believe that there is a risk to the supply chain at this time. Now I will turn the call over to Jonathan to review the results of our fiscal third quarter in more detail.