Risk Factors Update Summary
- Failure to comply with Nasdaq listing requirements could lead to delisting, impacting liquidity and market price.
- Our recent launch of new cash pay initiatives for Truvaga and TAC-STIM branded products may require significant investment. This could result in lost sales and harm our business.
- Our commercialization strategy may expose us to increased billing, cash application, and credit risks. This could result in lost sales and harm our business.
- Launching next generation app-enabled consumer product under Truvaga brand in 2024. This introduces a significant dependency on a third-party vendor for application development and management.
- We will be required to obtain additional funds to support commercial efforts for our VNS platform technology. This might result in increased financial strain.
- We may be subject to increased bad debt expenses due to bad debt expenses potentially impacting our results of operations and liquidity.
- Dependence on third-party software developers for the design and development of software for the new product. Failure to deliver required quantities or services could impede commercialization.
- Identified material weakness in internal control over financial reporting, affecting accurate financial reporting.
- An increasing portion of our 2024 sales will be made through Lovell's contract vehicles, concentrating our customer base further. This could adversely affect our business.
- Limited experience in selling app-enabled consumer wellness products, impacting the ability to forecast demand and inventory requirements.
- We intend to expand our direct-to-consumer business channel through ecommerce websites, increasing advertising and promotional activities in 2024. This will require significant investment.
- Material weakness in internal control over financial reporting related to payment security controls.
- Stock price volatility due to factors like product announcements, regulatory actions, and economic conditions.
- Reliance on third-party vendors for data storage and analytics, including cloud storage solutions, for the new Truvaga app-enabled consumer product. Any interruption or termination could significantly affect the product launch.
- We may face delays in payments by customers or disagreements with Lovell, impacting our results of operations and financial condition.
- Regulatory requirements for prescription gammaCore therapy and general wellness products, including expanding therapeutic indications, compliance, and marketing activities.
- Significant influence by principal stockholders and management owning approximately 24.4% of outstanding common stock.
- Risks related to intellectual property, including delays or failures in product development initiatives and potential lawsuits to protect proprietary technologies.
- Cybersecurity risk management strategy development and oversight by the Board of Directors.
- Cybersecurity risks, including data breaches, phishing scams, and cyberattacks, could disrupt operations and expose confidential information, leading to financial losses and reputational harm.
- Legal proceedings updates including dismissal of certain cases and ongoing defense in others.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=1560258&owner=exclude
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