Spexis provides business update and announces financial results for the full year 2022

Ad hoc announcement pursuant to Art. 53 LR

• USD 4.5 million capital commitment from SPRIM Global Investments to enable initiation of ColiFin COPILOT study; first patient dosing expected in mid-2023
• Reported solid safety and pharmacokinetics results from first-in-human study of inhaled murepavadin
• Announced positive renal impairment clinical trial results with balixafortide
  

ALLSCHWIL, Switzerland, May 29, 2023 (GLOBE NEWSWIRE) -- Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on rare diseases and oncology, today announced its financial results for the full year of 2022 and provided a strategic business update.

“With the recent closing of the capital commitment from SPRIM Global Investments, Spexis is well-positioned to execute on the clinical development of our Phase 3 ColiFin program, beginning with the initiation of our COPILOT study expected in the middle of the year,” said Jeff Wager, M.D., Chairman & CEO of Spexis. “In addition to the progress made with our lead asset ColiFin, we are highly encouraged by the accomplishments across our entire pipeline, including promising clinical results from both our balixafortide and inhaled murepavadin programs. Looking ahead to the rest of the year, we remain laser focused on driving each of these programs forward and will continue to diligently evaluate sources of capital to allow for the advancement of our pipeline through value creating milestones.”

Pipeline Status and Plans

The subsequent plans regarding further development of various programs in the Spexis’ pipeline are subject to the company raising additional funds and/or entering into partnering agreements.

Lead Program: ColiFin

ColiFin is being developed for the treatment of chronic lung infections in cystic fibrosis (CF) patients. Spexis has worldwide rights to ColiFin ex-Europe and is focused on developing the product first for the U.S. market. With a “Study may Proceed” letter from the United States Food & Drug Administration (FDA), Spexis is advancing ColiFin into a Phase 3 clinical program in adult and adolescent CF patients with moderate to severe lung function impairment and chronic Pseudomonas aeruginosa (PA) lung infection. PA infection accounts for two-thirds of CF chronic lung infections and is the leading cause of lung function decline and mortality in CF patients. The Phase 3 program includes the COPILOT safety and tolerability pilot clinical trial which will enroll 38 patients and evaluate and confirm the use of once or twice daily dosing for COPA, the planned single pivotal efficacy and safety Phase 3 trial.