Q3 report 2018

Financial Highlights

Initiator Pharma A/S is a Danish registered company, and is reporting its financial situation in Danish kroner (DKK). Initiator Pharma A/S was registered on May 2, 2016. 

Group earnings per share: period result divided by a number of 17 367 884 stocks (on 2018-09-30). Solidity: equity divided by assets.  

Business highlights in Q3 2018

• On August 22ndwe announced that we had started dosing of the first healthy subjects in the Phase 1 study with IPED2015 at MAC Clinical Trial Center in Manchester. A cardiovascular incident in one subject was observed, and the trial was put on pause while awaiting full examination of the case.
• On August 24thwe reported that the incentive warrant program approved by the AGM had been fully subscribed for. 
• On September 13thwe announced that the examination of the cardiovascular incident in the Phase 1 study reported on August 22ndhad been concluded, and that plans were to submit an amendment to the clinical trial protocol with the Medicines & Healthcare products Regulatory Agency, MHRA.UK.
• On September 21stwe announced that the amendment to the clinical trial protocol for the Phase 1 study with IPED2015 had been submitted to the Medicines & Healthcare products Regulatory Agency, MHRA, UK.

Significant events after this reporting period­

• On October 3rdwe reported that we received approval by MHRA in the UK to continue the Phase 1 trial for IPED2015.
• On October 11thwe announced the start of the subscription period for the series TO1 warrants.
• On October 29thwe announced that we are ready to resume dosing of IPED2015 in Phase 1 again, starting in the week of November 12th. 
• On November 6thwe announced the successful completion of the series TO1 warrant subscription period, raising a total of SEKM 12.7 in gross proceeds to the company.
• On November 8thwe announced that we had signed an option agreement with Saniona for a Phase 2 ready compound. 
• On November 23rdwe announced that we have re-started the Phase I with IPED2015.

Comments from the CEO

”With the initiation of the Phase 1 trial of IPED2015 during Q3:18 Initiator Pharma has made the transformation into a clinical stage company. We have big expectations that IPED2015 will become a first in class oral treatment of Erectile Dysfunction for the large number of patients that do not respond to drugs in the PDE5i class. Contingent on a successful completion on the Phase 1 trial we remain optimistic that we will be able to complete the clinical phase IIa Proof of Concept in the first half of 2019. 

While maintaining full focus on the development program for IPED2015 we are also looking forward to leveraging the expertise within Initiator Pharma by expanding our pipeline with attractive assets that can provide value to the company and shareholders in addition to helping patients with unmeet needs”

For more information, please contact

Claus Olesen, CEO, Initiator Pharma, Mobile: +45-61 26 00 35, E-mail: ceo@initiatorpharma.com

Torgeir Vaage, CFO, Initiator Pharma, Mobile: +47-924 05 235, E-mail: tv@initiatorpharma.com

About Initiator Pharma 

Initiator Pharma A/S is a Danish biotechnology company focusing on the development of innovative drugs, targeting key unmet medical needs within the central and peripheral nervous system. Our research is focusing on monoamine reuptake inhibitors, molecules that are affecting the synaptic concentrations of neurotransmitters such as dopamine, serotonin and noradrenaline. Our lead drug candidate, IPED2015 is targeting the medical condition Erectile Dysfunction (ED), and specifically patients with ED that are non-responsive to drugs within the PDE5i class, including the approved drugs ViagraÓ, CialisÓand LevitraÓ.

Initiator Pharma is based in Aarhus, Denmark.  Initiator Pharma is listed on Spotlight Stockmarket and has about 3.600 shareholders. Read more at www.initiatorpharma.com.