Oncology company Selvita (WSE:SLV) stated on Tuesday that it recorded a net loss (EBITDA excluding IFRS16 impact) of USD2.2m for the first quarter ended 31 March 2019.
This is a decline in earnings when compared with net loss of USD0.6m for the comparable quarter ended 31 March 2018.
Revenues attributable to non-dilutive grant sources of USD1.9m were generated for the quarter ended 31 March 2019, up over grant revenues of USD1.1m for the quarter ended 31 March 2018.
Research and development expenses of USD4.9m were recorded for the quarter ended 31 March 2019, a rise of USD2.2m from R&D of USD2.7m for the same period ended 31 March 2018, which was attributable to increase in costs of SEL120 development, as well as intensified research and development activities.
Additionally, the company's Investigational New Drug (IND) application to launch a Phase 1 study of selective CDK8 inhibitor SEL120 was approved by US Food and Drug Administration (FDA); Dosing of first patient in Phase 1 study of SEL120 is planned in the Q3 2019; and the split of oncology therapeutics and research services divisions into independent public companies is expected to be completed in the Q4 2019.
PepGen receives FDA designations for Duchenne muscular dystrophy therapy
Pfizer's PREVENAR 20 gains European Commission approval for paediatric pneumococcal vaccine
Astellas Pharma's CRESEMBA receives orphan drug and paediatric exclusivity from FDA
SK Biopharmaceuticals' cenobamate achieves 100,000 patient treatment milestone
Calliditas Therapeutics' Nefecon receives additional seven years orphan drug exclusivity from US FDA
Merck finalises acquisition of Harpoon Therapeutics Inc
RedHill Biopharma secures USPTO Patent for Talicia, extending protection through 2034
Celltrion USA submits CT-P39 Biologics License Application to FDA
iOnctura's first-in-class autotaxin cancer therapy granted US FDA Orphan Drug Designation
Epitomee submits Weight Loss Capsule for FDA approval in US
Calliditas Therapeutics TARPEYO receives seven years orphan drug exclusivity from US FDA
Camurus reports Oclaiz NDA accepted by FDA for acromegaly treatment
TME Pharma plans NOX-A12 Phase 2 trial in brain cancer after FDA IND clearance