ColiFin^® is an inhaled therapeutic for the management of chronic infections in cystic fibrosis (“CF”) patients. Although CFTR modulator therapy has transformed the lives of CF patients, it has also expanded the need for ColiFin® since the overwhelming majority of adult CF patients have irreversible lung damage causing them to suffer from chronic infections despite CFTR modulator therapy. Indeed, because CFTR modulator therapy will extend the lives of CF patients, the actual pool of CF patients needing a product like ColiFin^® will increase significantly over the next 20-30 years. Spexis in-licensed worldwide ex-European rights to ColiFin^® from PARI GmbH, a world-leader in nebulized drug delivery. ColiFin^® is approved in the EU and generates significant sales there. Spexis has negotiated a single P3 study pathway to approval with the U.S. FDA and holds both Orphan Drug and QIDP designations, providing 12 years of U.S. market exclusivity from the time of U.S. approval. ColiFin^® also has significant commercial opportunity in non-CF bronchiectasis and COPD, which represent markets many times larger than the CF market. We are seeking investors and corporate partners to support our P3 program and commercialize ColiFin^® in North America, Asia and in other markets.

Under development for the treatment of PA infection in CF patients. P1 trials are ongoing with development plans for both CF chronic PA infections and non-CF bronchiectasis.

and in many therapeutic indications such as solid tumors, hematologic malignancy and stem cell mobilization. Although a P3 trial in metastatic breast cancer read out negatively in mid-2021, Spexis believes there may be considerable therapeutic potential in other indications and is actively assessing same. We have partnered China rights to Fosun Pharma, a leading Chinese pharmaceutical company, but are seeking additional partnerships and investors to support further development efforts of balixafortide and, potentially, back-up compounds which we have identified and characterized arising from our macrocycle portfolio.