New Risk • May 31
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.67m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$1.9m free cash flow). Shares are highly illiquid. Negative equity (-US$2.0m). Revenue is less than US$1m. Market cap is less than US$10m (US$9.67m market cap). Announcement • May 19
Lakewood-Amedex Biotherapeutics Inc Announces Positive Data For The Advancement of Lead Candidate Nu-3 In Infected Diabetic Foot Ulcers Lakewood-Amedex Biotherapeutics Inc. announced positive data for its lead compound, Nu-3, as it advances towards a Phase 2 trial. Nu-3 is being developed as a topically delivered treatment for mildly infected diabetic foot ulcers (iDFU) designed to reduce the risk of antimicrobial resistance (AMR). The Company has conducted drug substance (the active ingredient) manufacturing process development for a few members of the Bisphosphocin® class and has completed several multikilogram scale under current Good Manufacturing Practices (cGMP) guidelines with high efficiency. In addition, process development advances have improved the cost of goods and have produced bulk drug substance with enhanced physical chemistry characteristics. The Company has also conducted drug product (the gel formulation) manufacturing process development and multikilogram quantities of the Nu-3 gel formulation have been manufactured under cGMP guidelines, and the product is suitable for use in clinical trials. In key stability testing, the Company has shown that the Nu-3 bulk drug substance material is stable for at least five years, and further examinations of the Nu-3 formulation have shown the drug product to be stable for at least two years. In addition, initial testing for bioburden (the presence of viable microorganisms) and antimicrobial effectiveness has demonstrated that the drug product has undetectable bioburden levels for at least two years and does not require additional preservatives to maintain antimicrobial effectiveness. The Bisphosphocin® class of compounds has been shown in vitro to rapidly kill bacteria through a pH and concentration dependent destabilization of the bacterial cell membrane. This mechanism of action offers the potential to reduce the threat posed by antibiotic-resistant bacterial strains, including Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococci (VRE), and others. Nu-3 is Lakewood-Amedex Biotherapeutics Inc.'s lead product being developed for the topical treatment of mildly infected diabetic foot ulcers (iDFU). Nu-3 belongs to a novel class of antimicrobials being developed by Lakewood-Amedex Biotherapeutics Inc. called the Bisphosphocin® class, which possess a unique mechanism of action that enables rapid elimination of a broad spectrum of bacteria, including resistant pathogens and biofilms. Data from initial exploratory clinical trials with Nu-3 using subclinical doses did not reveal any safety signals and showed a trend of positive antimicrobial response and improved wound healing. Based on these results, the Company plans to conduct an initial Phase 2a safety and dose response study of Nu-3 followed by a placebo-controlled Phase 2b dose comparative study. This study is also designed to determine the most appropriate administration regimen for Nu-3 gel formation in mildly infected diabetic foot ulcers. 
