Today Paion published its Q119 results. In the period, R&D costs reached €3.1m (Q118: €3.4m), driven by the ongoing EU Phase III study in general anesthesia. The company did not generate any sales in Q119, and its net loss was €3.2m (€3.1m). Cash and cash equivalents decreased by €1.6m to €15.6m.
The company filed for market approval with remimazolam (an ultra-short-acting intravenous benzodiazepine sedative/anesthetic) in the U.S. in April 2019 together with its partner Cosmo. PAION highlights that it also received a positive feedback after a pre-submission meeting with the European Medicines Agency (EMA) for the indication procedural sedation in the EU. The company will now focus on the development program in Europe, approval processes as well as commercial manufacture and supply chain for remimazolam.
Dr. Wolfgang Söhngen, PAION’s CEO, commented that: ‘We are now evaluating whether filing for market approval in procedural sedation based on the U.S. development program may be possible later this year. In addition, we will continue to work intensively on conducting the ongoing Phase III study in the EU in general anesthesia over the next few months, as well as on supporting our partners in further regulatory activities.’