INITIATOR PHARMA: Q3 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 2019-09-30). Solidity: equity divided by assets.  

Business highlights in Q3 2019

• On July 5th we announced that the warrant program 2019/2021, comprising a maximum of 434,197 warrants as resolved at the Annual General Meeting of 23 May 2019, had been fully subscribed.
• On August 13th we announced that the Phase 2a clinical study of IPED2015 in patients with Erectile Dysfunction was progressing well although recruitment of patients was taking slightly longer than planned, with the release of draft data from the study expected in early Q4:2019.
• On August 13th we announced that we had raised a bridge loan of SEK 5 mill with the aim of preparing the company’s other candidate drug IP2018 for the start of a clinical phase 2a trial.
• On September 3rd we announced that we had been awarded a grant from Innovation Fund Denmark of up to DKK 2 mill to support the ongoing clinical development program for IPED2015.
• On September 27th we announced that the dosing of the last patients in clinical Phase 2a Proof-of-Concept trial with IPED2015 had started, with anticipated release of draft data from the study expected during December 2019.

Significant events after this reporting period­

• On October 18th we announced that we had received an extension of the option agreement for the IP2018 drug candidate from Saniona until 31 March 2020 and furthermore opted to pay back the 5 MSEK bridge loan obtained earlier this year.

Comments from the CEO

A major focus for for Initiator Pharma during the third quarter of 2019 has been the Phase 2a Proof-of-concept trial. Following the succefull completion of the Phase 1 clinical trial in healthy subjects in June 2019 the first patients of the phase 2a trial were dosed in July.  While the recruitment of egible patinets has taken slighliy longer than anticipated we are confident that we will be able to report top-line results from the study before year-end.

Another focus for the Company has been the preparation of the IP2018 clinical trial application. We intend to finalize the application and submit it to regulatory authorities during quarter 1, 2020.  The filing of the CTA will enable us to exercise the option agreement that we have for this asset with Saniona. This will significantly strenghten the Initiator Pharma pipeline. 

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, CialisÓ and LevitraÓ.

Initiator Pharma is based in Aarhus, Denmark. Initiator Pharma is listed on Spotlight Stock Market and has about 3.500 shareholders. Read more at www.initiatorpharma.com.