Asarina Pharma AB (publ) Interim Report Q2 2019 released
Asarina Pharma CEO Peter Nordkild: “This has been a Quarter of important milestones: last patient in for our Phase IIb PMDD study, FDA approval of our IND for Sepranolone, Clinical Trial Approval for our Phase IIa Menstrual Migraine study and growing interest from future potential partners.”
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.
For further information, please contact:
Peter Nordkild, CEO, Asarina Pharma AB
Phone: +45 25 47 16 46
Jakob Dynnes Hansen, CFO, Asarina Pharma AB
Phone: +45 5132 3698
Erik Penser Bank AB
Phone: +46 8-463 83 00
About Asarina Pharma
We are a Swedish biotech company developing Sepranolone, the world’s first dedicated treatment for premenstrual dysphoric disorder (PMDD) and other menstrual-related conditions. Our product pipeline is built on over 40 years’ research into menstrual-related disorders like PMDD and menstrual migraine. With our new family of GAMSA compounds (GABAAModulating Steroid Antagonists), we aim to deliver a new generation of efficacious and safe drugs for still widely untreated conditions, thereby becoming a leading Women’s Health company.
The information above was provided by Asarina Pharma AB (publ) through the above contact person, for publication on August 20, 08.00, 2019.