H1 2019 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 23 157 178 shares (on 2019-06-30). Solidity: equity divided by assets.  

Business highlights in Q2 2019

• On April 29thwe called for the Annual General Assembly that was held on May 23rdand released our annual report for 2018.
• On June 10thwe announced that we had successfully completed the Phase 1 for IPED2015. The preliminary readout from the phase 1 has demonstrated that IPED2015 in general is safe and well tolerated at expected clinically relevant doses.  
• On June 25thwe announded the start of dosing of IPED2015 in the Phase 2a proof-of-concept clinical trial in erectile dysfunction patients.  

Significant events after this reporting period­

• On July 5thwe announced that the incentive program in Initiator Pharma, approved by the AGM on May 23rdhad been fully subscribed. If all warrants are exercised the company will issue a total of 434.197 new shares, representing 1.9% of issued shares, with par value of DKK 0.105 and with an exercise price of SEK 8,40. 
• On Aug 13thwe provided a status update on the ongoing Phase 2a study in patients with Erectile Dysfunction. The study is progressing well although recruitment of patients is taking slightly longer than planned. The reason for the slower recruitment is due to the aim of only including the correct medically qualified and motivated patients for the trial. This delay will alter the date for the final dosing of patients in the Phase 2a, and our current best estimate for releasing draft data from the study is early Q4.
• On Aug 13thwe announced that the company has secured bridge financing of SEK 5 million with the aim of preparing the company’s other candidate drug IP2018 for the start of a clinical phase 2a trial. With this bridge financing, the company is able to conduct activities for added value before seeking more long-term funding. The clinical phase 2a trial regarding IP2018 is expected to begin in early 2020. 

Comments from the CEO

The first half of 2019 has been very eventful, and full of activities for Initiator Pharma. To begin with, we have reported the successful completion of the Phase 1 clinical trial in healthy subjects in June 2019. Accordingly, IPED2015 has now been advanced to the Proof-of-Concept Phase 2 clinical stage. We aim to complete the dosing of patients shortly and subsequently to progress with data analysis to have the final read-out report in early Q4. Furthermore, we have completed our preclinical evaluation of IP2018 for which we have an option agreement in place with Saniona. We plan to exercise this option, and with the recently announed bridge financing we are proceeding with the preparatory activities for filing a CTA for a Phase 2a study before year-end. 

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 and has about 3.500 shareholders. Read more at www.initiatorpharma.com.