FINANCIAL HIGHLIGHTS 1 April – 30 June 2019
TOTAL OPERATING COSTS SEK 28.1M (11.5M)
NET RESULT -25.8M (-9.7M)
CASH AND CASH EQUIVALENTS (30 JUNE 2019): SEK 109.5M (9.7M)
SIGNIFICANT EVENTS DURING THE SECOND QUARTER
WHO classification of PMDD
In May PMDD (Premenstrual Dysphoric Disorder) was for the first time given its own classification code and classified as a gynaecological not psychiatric illness in the WHO’s new International Classification of Diseases, ICD-11, potentially impacting future prescription and reimbursement of both SSRIs and Sepranolone for PMDD.
CTA approval of menstrual migraine phase IIa trial
CTA (Clinical Trial Approval) was granted in the quarter in Finland, Denmark and Sweden for the Phase IIa proof-of-concept study of Sepranolone for menstrual migraine. The Study is expected to be completed before the end of 2020.
SIGNIFICANT EVENTS AFTER THE SECOND QUARTER
PMDD: Last Patient included in Phase IIb trial
In August we announced that the Last Patient had been included in our Phase IIb study in PMDD. With full enrolment topline results are expected to be released end March 2020.
MENSTRUAL MIGRAINE: FDA IND APPROVAL
In July, the FDA approved our IND application for Sepranolone in menstrual migraine, largely due to the excellent safety profile. This will have positive implications for our upcoming larger clinical PMDD trials.