Solana Company

Good day, and thank you for standing by. Welcome to the Helios Medical Technologies Q2 2022 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today. Lisa Wilson, please go ahead.

Thank you, Operator. Welcome to the second quarter 2022 Earnings Conference Call for Helios Medical Technologies. This is Lisa Wilson of Insight Communications, Investor Relations for Helios. With me on today's call are Dane Andreev, Helios Medical's President and Chief Executive Officer, and Jeff Matthiesen, Chief Financial Officer. At this time, all participants have been placed in a listen-only mode. Please note that this call is being recorded and access to the webcast can be obtained through the investor section of the Helios website at heliosmedical.com. Before we begin, I would like to remind everyone that our remarks and responses to your questions today may contain forward-looking statements that are based on the current expectations of management. These forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including those identified in the risk factors section of our most recent annual report on Form 10-K and quarterly report on Form 10-Q. Such factors may be updated from time to time in our other filings with the SEC, which are available on our website. All statements made during this call are as of August 15, 2022. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events, or otherwise, except as required by law. I would now like to turn the call over to Dane Andreef, President and Chief Executive Officer of Helios.

Thanks, Lisa. Welcome, everyone, to Helios Medical's second quarter 2022 earnings conference call. The second quarter saw the first commercial sales of our portable neural stimulation stimulator, or PONS device, which is indicated in the US for short-term treatment of gait deficit due to mild to moderate symptoms of multiple sclerosis, MS, and is to be used in conjunction with a supervised therapeutic exercise program. Gait dysfunction is an extremely common symptom among the estimated 1 million people in the U.S. suffering from MS. Over 70% of patients report difficulties walking, yet there remains a huge unmet need in this area. Until now, treatment options have been limited, but 14 weeks of PONS therapy has demonstrated significant gait improvement when compared to physical therapy alone. PONS therapy is the only available portable and readily accessible neurostimulation therapy that promotes neuromodulation and may lead to neuroplasticity, which is the brain's ability to modify, change, and or adapt in response to modulation of brain activity. It is safe, effective, and offers patients hope and neurologists a new tool in their tool belt. We are pleased to report that Pons continues to see a promising reception in the marketplace. We have received more than 300 inquiries to date that we are actively following up on and are working to convert as many as possible to prescriptions. We have also added a video advertisement at our landing page, www.ponstherapy.com, in the past week, which we believe will help drive interest and inquiries in ponds. I encourage each of you to take a look at it. Because the company has four stakeholders, patients, payers, physical therapists, and physicians, we have seen a few bottlenecks in the process of getting pond therapy to those who need it. One major impediment, has been in training the physical therapists who wish to treat MS patients with PONS therapy. Historically, therapists were trained through an in-person multi-day course with only five to 10 people able to participate at any one time. This has resulted in a slow process, leaving many physicians unable to find a trained physical therapist to fill the prescription. To solve this problem, we've implemented a self-paced online training module, which can be completed in three hours or less instead of over several days. Though the module was only introduced in mid-July, we've already onboarded practitioners from clinics around the United States, including UC Health Sports Med in Colorado, NEA Baptist in Arkansas, St. David's Rehabilitation Hospital in Austin, in the University of Rochester Medical Center. We currently have more than 80 physical therapists already trained or in the process of getting registered for or completing training. Another hurdle to PONS use will be lessened when we roll out our telehealth e-commerce online pharmacy initiative later this year. PONStherapy.com is an increasingly robust site, but we expect the direct-to-consumer e-platform to be a game changer for physicians and patients. Once live, the platform will be immediately available in all 50 states and will include a network of fully licensed providers with e-prescribing capabilities. Currently, it could take a patient several weeks to set up an appointment with their neurologist or primary care physician. Through this site, patients will have the ability to match with practitioners and make appointments online, shrinking the four-week window to as low as 24 hours. In addition, the online store will give patients the option to have the PONS device delivered directly to their door. Currently, sales in the U.S. are on a cash pay basis. The established US list price for PONS device is $25,700, comprised of a one-time cost of $7,800 for the controller and $7,900 for the mouthpiece. As we pursue commercial and government reimbursement programs, we want to make sure cost is not a barrier. To access on-label PONS therapy at a significantly reduced price, patients can now use the patient therapy access program. PTAP is expected to run through December 31st, 2022. In addition, we are setting up a registry program for all MS patients treated with PON therapy, which will collect important health economic information to support the value of PON on key therapeutic outcomes and help generate evidence for coverage. We expect the registry to be available to HCPs and patients by the fall. Helping all stakeholders understand the functional outcomes of PONS therapy and the ways it can improve the quality of life is an important part of reaching the broadest group of patients possible. PONStherapy.com website is one way we're working towards this goal. And our therapeutic experience program is another. TAP is an open label observational trial designed to gather information on the extent to which patient's adherence to a PONS therapy regimen can lead to a meaningful therapeutic outcome. By partnering with some of the nation's premier academic medical centers, we can observe PONS therapy in a real-world setting while keeping key opinion leaders in MS management build their knowledge. Through TEP, we aim to treat 40 to 50 patients across 10 to 12 planned centers of excellence, treating neurologists and neural rehabilitation centers identified as having the greatest potential to be early adopters of our technology. During the second quarter, We were thrilled to add the Shepherd Center in Atlanta as one of our centers, and we are currently engaged with approximately a half a dozen centers, which we hope to add in the near future. We also project to enroll the first patients for TEP late in August and expect to complete enrollment by early next year. Also by the end of the year, we expect to get additional clinical evidence to support long-term durability upon therapy for MS. Before I turn it over to Canadian Activities, I want to give a brief update about the pilot trial in stroke, which we partnered on with the Medical University of South Carolina. The study is designed to evaluate dynamic balance and neuromodulation in chronic stroke survivors. neuromodulatory translingual stimulation delivered using PONS therapy. We anticipate enrollment in the MUSC trial will commence soon and expect it to have full enrollment by mid 2023. Turning to our Canadian activities, since 2019, PONS has been authorized for sale in Canada for chronic balance deficit due to mild to moderate traumatic brain injury, and subsequently for the treatment of gait deficit due to mild to moderate symptoms from MS. We now have 41 authorized PONS clinics in Canada, up from 37 at the end of 2021. In addition, we currently have small trial programs with a few insurance carriers in Canada evaluating the benefit of PONS therapy which we hope will lead to coverage by some or all of those carriers in the near future. Having said that, while we have gained valuable data from our patients in Canada, some of which we've used to achieve FDA authorization in the US, our sales have not reached the levels we have targeted. We are currently evaluating additional measures and alternatives to achieve greater market adoption in Canada. With that, let me turn the call over to Jeff to discuss our second quarter financial results in detail.