Nuo Therapeutics (AURX) Risk Analysis

We outsource the manufacturing of various Aurix product components to contract manufacturers. While we believe these manufacturers demonstrate competency, reliability and stability, there is no assurance that one or more of them will not experience an interruption or inability to provide us with the components needed to satisfy customer demand. While most of the components of Aurix are generally readily available on the open market, a reagent used for Aurix - bovine thrombin (Thrombin-JMI or "TJMI") - is available solely through Pfizer, with which we have a long-standing supply agreement. Historically, we have used single suppliers for several components of the Aurix product line; however, when feasible, we obtain alternative suppliers of components, such as in 2025 when we established a dual supply for an ascorbic acid reagent component of Aurix. In Spring 2026, we became aware that Pfizer was experiencing challenges regarding regular uninterrupted supply of commercially available TJMI. Our understanding has been that the TJMI supply challenges related to a diluent co-packaged with the lyophilized thrombin vial in the TJMI product. We use only the lyophilized thrombin (not the diluent) as a component in the Aurix reagent kit. Nonetheless, in late June 2026, Pfizer notified us that TJMI would be unavailable with recovery expected in early 2027. We had previously been addressing the potential unavailability of TJMI in whole or in part via possible alternative supply arrangements. Upon notice of TJMI outage in late June 2026, we initiated contact with an FDA drug shortage group to discuss possible mitigation approaches to an impending Aurix shortage. In addition, we remain engaged with Pfizer on supply to us of bulk lyophilized thrombin in different packaging configurations with potential availability prior to 2027. There can be no assurance as to when or whether the supply of TJMI will resume, in its original or different packaging configurations, or whether the supply of TJMI will resume at preexisting levels. Further, upon a resumption of its supply, Pfizer may unilaterally raise the price or alter its allocation of TJMI to its customers including us or may decline to renew or may terminate the supply agreement. Due to the TJMI supply chain interruption, the Aurix branded and the Private Label products entered a temporary out-of-stock situation in early August. While we have mitigated the thrombin supply outage as of the filing date of the Quarterly Report with an alternative supply for at least the short term, we are continuing to pursue longer-term alternative approaches, supplies, and suppliers of thrombin to use in the Aurix product line. These alternatives include seeking FDA regulatory relief, utilizing human recombinant thrombin, and establishing sources of supply from outside the United States. Despite our efforts, we may be unable to obtain, utilize, or establish these alternatives in the long term, or at all, at prices or quality levels that are acceptable to us or that meet applicable regulatory clearance or approval requirements, including import and customs requirements. If these alternative approaches are insufficient or untimely, or if the TJMI supply chain interruption is more than temporary, our ability to supply Aurix to customers directly and through distributors would be disrupted and our Aurix commercialization efforts and operating results would be adversely affected. If a temporary or permanent interruption in the supply of any other reagent were to occur, or the manufacturing costs charged by any supplier exceed what we can reasonably afford, we would have to seek alternative sources of supply. There is no assurance we would be able to identify a suitable second source of supply or do so without significant delay. Despite our efforts to maintain an adequate supply of inventory, the loss a supplier or its inability to provide us with an adequate supply of a reagent could cause delay in manufacture of our product, thereby impairing our ability to meet the demand of our customers and causing significant harm to our business. Any disruption of this nature or increased expenses could harm our commercialization efforts and adversely affect our operating results.