Announcement • Jul 02
Advicenne Announces Unlimited Renewal of Marketing Authorization for Sibnayal in United Kingdom Advicenne S.A. announced the unlimited renewal of the Marketing Authorization (MA) for Sibnayal (a fixed-dose combination of potassium citrate and potassium bicarbonate) for the treatment of distal Renal Tubular Acidosis (dRTA) in the United Kingdom. The Medicines and Healthcare products Regulatory Agency (MHRA) has granted the unlimited renewal of MA for Sibnayal effective June 2026. This renewal, which is mandatory five years after the initial grant, definitively validates the MA in the United Kingdom. Following the renewal of the marketing authorization in the European Union, the decision by the British authorities highlights the therapeutic profile of Sibnayal in the treatment of dRTA, a serious renal condition affecting children and adults. Advicenne’s regulatory program is particularly robust, with several marketing authorizations obtained for Sibnayal in the Gulf countries, the recent reimbursement approvals for Likozam and Sibnayal in the French market, as well as the review of the registration dossier for ADV7103 by the U.S. Food and Drug Administration and a decision expected on September 3, 2026. Sibnayal (ADV7103) has received its Marketing Approval for distal renal tubular acidosis in EU, GB, KSA and UAE, and has been filed for a US NDA. ADV7103 is currently in late-stage development in cystinuria in Europe and the US. Announcement • May 23
Advicenne S.A. Announces Board Changes Advicenne S.A. announced changes to its governance following its Annual General Meeting (AGM) held on May 21, 2026. The Annual General Meeting appointed Mr. André Ulmann, a director, and Mr. Adrian Hepner, an independent director, to three-year terms. At the board meeting held following the AGM, Mr. Didier Laurens was appointed Chairman of the Board. Ms. Charlotte Sibley was appointed Chair of the Remuneration Committee (Remco). New Risk • May 11
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -€4.1m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. 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 (-€4.1m free cash flow). Share price has been highly volatile over the past 3 months (13% average weekly change). Negative equity (-€26m). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (€2.4m net loss in 2 years). Shareholders have been diluted in the past year (15% increase in shares outstanding). Market cap is less than US$100m (€12.3m market cap, or US$14.5m). 
