Initiator Pharma started dosing of IPED2015 in the Phase 2a, PoC  trial

Regulatory June 25, 2019 PRESS RELEASE 25 June 2019 Initiator Pharma A/S, a biotech company that is developing a novel treatment of erectile dysfunction today announced that it started the dosing of IPED2015 in erectile dysfunction (ED) patients in the Phase 2a, Proof-of-Concept (cPoC). The Phase 2a/cPoC trial is a randomized, double-blind, placebo-controlled cross-over study in ED patients. The aim of the study is to investigate the safety, tolerability, pharmacokinetics and efficacy (RigiScan assessment) of IPED2015 executed at the MAC Clinical Research site. In the crossover study the patients will be treated with placebo or with IPED2015 resulting in 12 patients in each treatment arm. 'This is a standard design considered sufficient to demonstrate efficacy in ED patients' explains Chief Medical Officer, professor dr med Ulf Simonsen. `We are delighted with the initiation of the Phase 2a/cPoC trial based on the just finalized Phase I study. We are looking forward to completing the Phase 2a clinical trial phase during this Summer followed by data analysis, where we hope to demonstrate efficacy in ED patients and generate cPoC that will support the ongoing efforts to enter a deal setting with IPED2015' says CEO, Claus Elsborg Olesen. For additional information about Initiator Pharma, please contact: Claus Elsborg Olesen, CEO Telephone: +45 6126 0035 E-mail: [email protected] This information is the information that Initiator Pharma is required to disclose under the EU Market Abuse Regulation. The information was provided under the above contact person's auspices, for publication on June 25th, 2019. About Initiator Pharma Initiator Pharma is a Biotech company established in Aarhus, Denmark. Its main asset IPED2015 represents a novel treatment paradigm for the treatment of Erectile Dysfunction (ED) and will improve the quality of life for the growing number for patients (and their partners) that do not respond or cannot be treated with the current marketed medication. About Erectile dysfunction Erectile dysfunction is sexual dysfunction characterized by the inability to develop or maintain an erection of the penis during sexual activity. ED affects more than 150 million men worldwide and that number is expected to increase to more than 320 million by 2025, fueled by aging demographics and increasing prevalence of life style diseases such as diabetes. ED patients have decreased quality of life due to various psychosocial factors such as low self-esteem, depression, sadness, anger, frustration, anxiety, and relationship problems (1,2, 3). 1. Shabsigh R, et al. (1998) Increased incidence of depressive symptoms in men with erectile dysfunction. Urology52(5):848-852. 2. Mccabe MP, Althof SE (2014) A systematic review of the psychosocial outcomes associated with erectile dysfunction: Does the impact of erectile dysfunction extend beyond a man's inability to have sex? J Sex Med11(2):347-363. 3. Nguyen HMT, Gabrielson AT, Hellstrom WJG (2017) Erectile Dysfunction in Young Men-A Review of the Prevalence and Risk Factors. Sex Med Rev5(4):508-520.

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