Spexis provides business update and announces financial results for the first half of 2023

Ad hoc announcement pursuant to Art. 53 LR

• Balixafortide, a potent CXCR4 inhibitor, to be evaluated for the treatment of pancreatic ductal adenocarcinoma (PDAC)
• Spexis closed capital commitments totaling USD $7.5 million supporting Phase 3 ColiFin program in cystic fibrosis (CF) infections
• COPILOT study expected to initiate in fourth quarter 2023
• Appointed Gonçalo Bernardes, PhD, as acting Head of Chemical Biology
• Announced strong safety and pharmacokinetics results from first-in-human study with inhaled murepavadin, a novel macrocycle compound
• Engaged Maxim Group LLC as M&A advisor to evaluate strategic transactions of which Spexis would be the surviving company
• Business update conference call to be held in October
  

ALLSCHWIL, Switzerland, Sept. 28, 2023 (GLOBE NEWSWIRE) -- Spexis AG (SIX: SPEX), a clinical-stage biopharmaceutical company focused on macrocycle therapeutics for rare diseases and oncology, today announced its financial results for the first half of 2023 and provided a strategic business update.

“Spexis remains on track to deliver on the potential of our robust pipeline with multiple clinical development milestones on the horizon,” said Jeff Wager, M.D., Chairman & CEO of Spexis. “We anticipate initiating our Phase 3 ColiFin program beginning with the COPILOT study in the fourth quarter supported by our financial partner on this program, SPRIM Global Investments. In addition, we have completed our initial analysis of further indication development potential for balixafortide. Based on our analysis, we are excited to announce balixafortide’s new focus on the treatment of PDAC where patients have long faced bleak and limited treatment options. Balixafortide’s well-documented and encouraging selective antagonism of the CXCR4 chemokine receptor and the new preclinical research illustrating its potential in PDAC have encouraged the company to focus our resources on the clinical development of balixafortide in this indication. We look forward to providing additional updates as our novel macrocycle derived pipeline continues to advance.”

Pipeline status and plans

The plans outlined below regarding the further development of various programs are subject to Spexis raising additional funds and/or entering into partnering agreements.

Lead Program, ColiFin:

Spexis is committed to progressing its lead program ColiFin, which is currently being developed to treat chronic lung infections in cystic fibrosis patients, but which also has strong therapeutic potential in non-CF bronchiectasis (nCFBE) and chronic obstructive pulmonary disease (COPD), as these patients also suffer from chronic Pseudomonas aeruginosa (PA) lung infections. ColiFin has been approved in the EU as an inhaled therapeutic and holds Orphan Drug and QIDP designations in the U.S.