Full year report for 2018
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.
|Fourth Quarter (2018-10-01 – 2018-12-31)|
|Full Year (2018-01-01 – 2018-12-31)|
Group earnings per share: period result divided by 23 157 178 shares (on 2018-12-31).
Solidity: equity divided by total assets.
Business highlights in Q4 2018
- On October 3rdwe announced that we had received approval for an amendment to the clinical trial protocol to the Medicines & Healthcare products Regulatory Agency, MHRA, UK as well as the Ethics Committee, EC.
- On October 29thwe announced that we were ready to continue the Phase Clinical trials with IPED2015 in the week of the 12thof November.
- On November 6thwe announced that we had raised SEKM 12,7 in gross proceeds from the TO1 warrant program and a directed share issue in connection with the warrant program.
- On November 8thwe announced that we had signed an option agreement with Saniona AB, for a phase 2 ready drug candidate.
- On November 23rdwe announced that we had completed first dosing of the re-started Phase I study.
Significant events after this reporting period
Update on the ongoing Phase 1 trial for IPED2015
The Phase 1 trial is progressing well, and no clinically significant adverse events have been observed since the restart of the trial. We are now approaching the expected clinically relevant dose levels and the current data is still supportive, and we will continue executing the trial at its current plan. We expect to report phase 1 data during H1:2019. If successful we plan to immediately progress the compound into a phase 2a clinical proof of concept trial, with headline data available mid 2019.
Comments from the CEO
”In Q4 we re-started the clinical phase 1 trial after the cardiovascular incident that was communicated to the market on August 22nd, and reported that the first cohort of healthy subject showed no clinical signs. We are very pleased with the progress of the Phase 1 trial and satisfied with the general conductance of the trial by MAC Clinical research, including the continuing recruitment of healthy subjects. We are looking forward to completing the Phase I study and are now preparing for the upcoming Phase 2a trial. We appreciate the support from existing and new shareholders for the succefull close of the TO1 warrant program and look forward to report data from our Proof-of- Concept study around mid-year”.
For more information, please contact
Claus Olesen, CEO, Initiator Pharma, Mobile: +45-61 26 00 35, E-mail: firstname.lastname@example.org
Torgeir Vaage, CFO, Initiator Pharma, Mobile: +47-924 05 235, E-mail: email@example.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.