Limited Operating History and Recurring Losses Continues: The company has a limited operating history and has incurred significant losses since inception, with no assurance of achieving profitability in the future, which raises substantial doubt about its ability to continue as a going concern.

Regulatory Approval Uncertainty and Delays: The company's products are subject to extensive and rigorous regulation by governmental authorities, including the FDA, and there is no guarantee that necessary regulatory approvals will be obtained in a timely manner or at all, which could significantly delay or prevent commercialization.

Dependence on Product Commercialization Success: Nexgel's future success is largely dependent on the successful development, regulatory approval, and commercialization of its current and future hydrogel products, and failure to achieve market acceptance could have a material adverse effect on its business and financial condition.