Nexalin Technology, Inc., a pioneering entity in the realm of neurostimulation devices aimed at alleviating mental health disorders, has unveiled its Form 10-Q report for the third quarter of 2024.
This document elucidates the company’s financial standing and operational undertakings, emphasizing pivotal metrics and strategic maneuvers.
Financial Highlights
- Revenues, net: $0.018 million, signifying a 50% decline compared to the same epoch in 2024, attributed chiefly to diminished licensing fee revenues and a decrease in equipment sales.
- Gross profit: $0.014 million, reflecting a gross margin of 78%, a rise from 65% in the previous year, propelled by an increased share of licensing fees.
- Loss from operations: $(2.346) million, an improvement over the $(2.509) million loss recorded last year, driven by a reduction in selling, general, and administrative expenditures.
- Net loss: $(2.276) million, reflecting a 7% enhancement from the $(2.448) million loss in the preceding year, indicative of improved cost control measures.
- Net loss per share attributable to common stockholders – Basic and Diluted: $(0.13), bettering the $(0.23) in the prior year, attributing this to a higher weighted average of outstanding shares.
Business Highlights
- Revenue Segments: The company primarily generated revenue through licensing and treatment fee agreements, alongside sales of equipment such as boards, electrodes, and cables for patients. The revenue drop was largely ascribed to timing issues related to customer demands affecting both licensing and equipment sales.
- Geographical Performance: Revenue continues to emanate from devices sold prior to the FDA’s reclassification announcement, particularly in China, where the Gen-2 device has received approval for the treatment of insomnia and depression.
- Sales Units: The company successfully shipped devices to Oman, with the inaugural shipment taking place in January 2024, followed by additional deliveries in February 2024, marking the operational launch of the end user’s clinic.
- New Product Launches: In development are new devices, Gen-2 SYNC and Gen-3 HALO, which are currently undergoing the Q-submission process for FDA review. These innovations are tailored to deliver a 15 milliamp waveform for enhanced brain stimulation.
- Future Outlook: The company intends to initiate clinical trials for the Gen-2 SYNC and Gen-3 HALO devices within the U.S., aspiring towards FDA clearance for commercialization. The FDA’s acceptance of the Q-Submission for the Gen-2 SYNC system targeting Alzheimer’s and dementia signifies a crucial advancement toward FDA-sanctioned clinical studies in the U.S.
- Strategic Initiatives: A virtual clinic platform is being cultivated to empower physicians in diagnosing and prescribing treatments within a tele-psychiatry framework, thereby enhancing patient privacy and convenience.
- Regulatory Developments: The FDA has sanctioned the company’s Q-Submission for the Gen-2 SYNC system, inching closer to FDA authorization for clinical explorations involving Alzheimer’s and dementia.
- International Expansion: Regulatory approval has been secured for the Gen-2 device in Brazil and Oman, permitting the treatment of insomnia and depression in these territories.
- Military & Government Engagement: The establishment of a Military & Government Advisory Board aims to nurture relationships with U.S. federal entities and public sector organizations, with a vision for integrating its devices into the U.S. military and governmental frameworks.
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