H1 2018 report

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 2018-06-30). Solidity: equity divided by assets.  

Business highlights in Q2 2018

• On April 5thwe announced that the rights issue had been oversubscribed, raising SEK 19.1 million to the company before issuing costs and SEK 16.8 net of issuing costs.
• On May 3rdwe called for the Annual General Meeting, to take place on May 25th, and published our Annual Report for 2017.
• On May 23rdwe announced that we have filed a Clinical Trial Application, CTA for Drug candidate IPED2015 with the Medicines & Healthcare products Regulatory Agency, MHRA.UK.
• On June 4thwe announced that we had selected MAC Clinical Research Unit as our collaborator for the upcoming clinical development of IPED2015
• On June 26thwe announced that the Medicines & Healthcare products Regulatory Agency, MHRA.UK had approved our CTA for the Phase 1 for IPED2015.

Significant events after this reporting period­

• On August 22ndwe announced that we had started dosing of our first Phase 1 trial with IPED2015 at MAC Clinical Research, Manchester, UK. The general conduct and start of the study went well with no clinical adverse reactions recorded. However, a cardiovascular incident in one subject was observed – there were no clinical symptoms but a technical abnormality on the readout of the cardiac function was observed.The company and its connected experts are currently exploring this incidence, and resuming of dosing will await the full examination of this case.
• On August 23rdwe announced that the warrant program 2018/2020, comprising a maximum of 434,197 warrants as resolved at the Annual General Meeting of 25 May 2018, has been fully subscribed. Subscription of warrants have been submitted by employees, board members and key consultants, in total 7 persons, according to Appendix 2 to the AGM protocol from 25 May, 2018.

Comments from the CEO

” With the successful completion of the preclinical development of IPED2015 in January, followed by the CTA filing in May and subsequent approval by MHRA in late June Initiator Pharma is now ready to become a clinical stage company. We have just announced that the dosing in our First-in-Man clinical trial with our Erectile dysfunction drug candidate was started in August, and we aim to conduct the Phase 2a PoC during first half of 2019”

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 Stock Market and has about 3.400 shareholders. Read more at www.initiatorpharma.com.