Risk Factors Update Summary
- Increased costs related to public company operations will require hiring additional personnel. This change might result in higher operational expenses.
- The company had no income from continuing operations as of December 31, 2023, and incurred losses of $16,205,252.
- Reduced full-time employees from seven to nine and part-time employees from eight to one. This change may impact operational efficiency and productivity.
- The company expressed substantial doubt about its ability to continue as a going concern, requiring additional funding.
- Emphasized the critical need for substantial additional funding to support ongoing activities, commercialization efforts, and business growth. Failure to secure funding may lead to delays or reductions in development programs.
- Addition of new product candidates may require additional capital, with a working capital of $951,495.
- Compliance with healthcare regulations may become more costly and difficult, impacting business growth.
- The company identified a material weakness in internal financial controls, impacting financial reporting and market value.
- Reprioritized development to focus on commercializing cosmetic products, ceasing clinical studies of product candidates. This change could result in a delay in generating revenue.
- Highlighted the importance of managing inventory efficiently to meet demand, control costs, and avoid inventory-related challenges that could harm long-term growth prospects.
- Management estimates the need to raise additional capital in the next twelve months for development and commercialization.
- The ongoing conflicts globally could disrupt the supply chain, impacting business operations and data security.
- New regulatory requirements for cosmetic products under MoCRA could lead to significant compliance costs.
- Increased the number of skincare products to be launched in 2024 from one to ten. This expansion may require additional resources and marketing efforts.
- Expanded the description of potential risks related to product liability lawsuits, emphasizing the impact on resources, liabilities, and commercialization efforts.
- Changes in the regulatory environment may impact financial arrangements, sales, and marketing programs.
- Added the need to resolve FDA comments on Bone Healing Accelerant program before initiating clinical studies. Failure to resolve may lead to a denial of regulatory approval.
- The company may face challenges in managing growth, with plans to increase personnel and resources.
- The volatility of the stock market may affect the trading price of the company's common stock.
- Failure to comply with regulatory requirements could result in penalties, fines, or operational disruptions.
- Provisions in the company's certificate of incorporation may discourage unsolicited takeover proposals.
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=1842939&owner=exclude
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