Core Insights - Helius Medical Technologies, Inc. will present the final results of the PoNSTEP study, which confirms the efficacy of the Portable Neuromodulation Stimulator (PoNS) device for improving gait in individuals with multiple sclerosis (MS) [1][2] - The study highlights a statistically significant relationship between adherence to PoNS therapy and improvement in gait, indicating that consistent use leads to sustained benefits [3][4] Study Overview - The PoNSTEP study was a three-phase, real-world therapeutic experience designed to evaluate the impact of adherence on gait deficits and long-term outcomes in MS patients [3][8] - Participants underwent two weeks of supervised therapy, followed by 12 weeks of combined clinic and at-home use, concluding with a six-month follow-up to assess the durability of improvements [3][9] Key Findings - Stronger adherence to PoNS therapy resulted in better therapeutic outcomes, with highly adherent participants achieving over 6 points improvement in their Dynamic Gait Index (DGI) scores during the first 14 weeks [4][5] - More than 95% of participants maintained their level of improvement six months post-treatment, demonstrating the durability of the therapy's effects [5][7] Clinical Implications - The study provides evidence of the effectiveness of neuromodulation and neuroplasticity in rehabilitating gait deficits in MS patients, marking a significant advancement in treatment options for this population [7][10] - PoNS therapy is now accessible through insurance via the U.S. Department of Veterans Affairs and Department of Defense, with some commercial healthcare providers beginning to reimburse the device [7][12] About PoNS Device - The Portable Neuromodulation Stimulator (PoNS) is a non-implantable device that delivers neurostimulation through a mouthpiece, used in conjunction with physical rehabilitation exercises to improve balance and gait in MS patients [12][14] - The device is indicated for short-term treatment of gait deficits due to mild-to-moderate MS symptoms and is prescribed for patients aged 22 and older [12][13]

Financial Data and Key Metrics Changes - For Q1 2025, the company reported a net loss of $5.5 million, an improvement from a net loss of $6.5 million in Q1 2024 [37] - Loss from operations decreased to $3.8 million from $6 million in the same quarter last year [37] - Research and development expenses were $800,000, down from $1.7 million in Q1 2024, while general and administrative expenses decreased to $2.9 million from $4.3 million [37][38] Business Line Data and Key Metrics Changes - NRx has advanced its lead candidates, NRx 100 and NRx 101, in the regulatory process with the US FDA, aiming for revenue generation in the near term [6][10] - The company has established a network of clinics under Hope Therapeutics, which is expected to be revenue-generating and profitable soon [10][34] - The company anticipates clinic revenue well before the end of the year, with a focus on non-dilutive financing for clinic acquisitions [7][17] Market Data and Key Metrics Changes - The market for NRx 100, an intravenous preservative-free ketamine for treating suicidal depression, is projected to be significant, with potential sales reaching billions [27][26] - The company expects the market for NRx 101, targeting bipolar depression with suicidality or akathisia, to exceed $2 billion initially and potentially over $5 billion broadly [33][28] Company Strategy and Development Direction - NRx aims to address the national epidemic of suicidality, depression, and PTSD through innovative medicines and direct patient care via Hope Therapeutics [6][10] - The company plans to establish a national network of interventional psychiatry clinics, combining neuroplastic treatments and protocols [33][34] - NRx is focused on gaining FDA approval for its products to expand patient access and improve treatment options for mental health conditions [26][39] Management's Comments on Operating Environment and Future Outlook - Management highlighted the increased focus from the US government on treating suicidal depression and PTSD, particularly in military and veteran communities [9] - The company is optimistic about its path to revenue generation and profitability by the end of 2025, supported by ongoing financing discussions and partnerships [38][36] - Management expressed confidence in the potential for NRx 100 and NRx 101 to provide life-saving treatments and significant market opportunities [27][39] Other Important Information - NRx has filed a patent for its novel preservative-free formulation of NRx 100, potentially protecting the product until 2045 [11][23] - The company has manufacturing capacity to supply over 1 million doses of ketamine per month upon FDA approval [11][22] - NRx is navigating the complexities of acquiring medical treatment facilities under state regulations as part of its growth strategy [16][34] Q&A Session Summary Question: What does the recent IP buy you if approved? - Management indicated that the strength of the patent application is believed to be strong, potentially providing market exclusivity for an extended period if the preservative-free ketamine is approved [41][42] Question: Consideration for NRx 100 going international? - Management confirmed intentions to make NRx 100 available internationally, noting that European countries are more sensitive to toxic substances, which could enhance market potential [47]

Core Insights - Nexalin Technology, Inc. has reconstituted its Scientific Advisory Board (SAB) to enhance its focus on Alzheimer's disease, reflecting a strategic prioritization within its clinical development pipeline [1][3] - The newly appointed members of the SAB include Dr. Mingxiong Huang, Dr. David Owens, and Dr. Abe Scheer, who bring extensive expertise in neurology and neuroimaging [2][3] - The company plans to initiate new Alzheimer's-focused clinical studies in Q3 2025, incorporating cognitive testing and imaging biomarkers to assess treatment efficacy [11][12] Company Developments - The restructuring of the SAB aims to provide scientific and clinical oversight for Nexalin's initiatives in neurodegenerative and neuropsychiatric disorders [2][3] - Nexalin's proprietary Deep Intracranial Frequency Stimulation (DIFS™) technology is designed to penetrate deep brain structures associated with cognitive decline and mental illness [3][12] - The company emphasizes the potential of DIFS™ to promote neuroplasticity and functional recovery, particularly in memory and executive function areas [3][12] Advisory Board Expertise - Dr. Mingxiong Huang specializes in magnetoencephalography (MEG) and neuroimaging, with over 25 years of experience in advanced imaging techniques for neurological disorders [4][5] - Dr. Abe Scheer has over four decades of experience in neurology and psychiatry, and has previously served on Nexalin's SAB [6][7] - Dr. David Owens, the Chief Medical Officer, is a board-certified neuroradiologist with expertise in advanced imaging techniques and clinical research on transcranial stimulation therapies [8][10] Future Directions - The SAB will guide the scientific direction and clinical strategy for Nexalin's Alzheimer's initiatives, ensuring adherence to regulatory standards and scientific rigor [11][12] - The company aims to leverage the combined expertise of the SAB members to advance its technology through clinical trials addressing Alzheimer's disease [3][11]

Core Insights - Helius Medical Technologies has received reimbursement approval for the PoNS Device from United Healthcare, marking it as the second major healthcare provider to do so after Anthem [1][2] - The approved reimbursement amount totals $18,100, which reflects the out-of-network adjusted list price [2] Company Overview - Helius Medical Technologies is a neurotech company focused on addressing neurologic deficits through its Portable Neuromodulation Stimulator (PoNS) [3] - The PoNS device is designed to improve balance and gait deficits, particularly in patients with multiple sclerosis (MS) [4] Product Details - The PoNS Device is a non-implantable therapy that delivers neurostimulation via a mouthpiece, intended for use alongside physical rehabilitation exercises [4] - It is indicated for short-term treatment of gait deficits due to mild-to-moderate MS symptoms and is prescribed for patients aged 22 and older [4] Clinical Validation - The PoNS Device has demonstrated effectiveness in treating gait and balance issues, significantly reducing fall risks in stroke patients in Canada [5] - It has received authorization for multiple indications in Canada and is also approved for use in Australia [5]