Specializing in bioengineering, Spexis focuses on creating treatments for antibiotic-resistant bacterial infections, particularly for patients with chronic respiratory diseases like cystic fibrosis. Their lead product candidate, ColiFin®, is an inhaled colistimethate sodium product that has already been approved and marketed in Europe for cystic fibrosis patients. In the US, ColiFin® has Orphan Drug and Qualified Infectious Disease Product designations, providing 12 years of market exclusivity. Spexis has received a "Study May Proceed" letter from the FDA for a phase 3 study evaluating ColiFin® in cystic fibrosis patients, with the trial design endorsed by the Cystic Fibrosis Foundation.