Q3 report 2021

The third quarter started off with the successful capital raise that provided the resources required for expanding our portfolio with our IPTN2021 program for Trigeminal Neuralgia. The first step was the directed issue in May, which provided close to SEK 30 million, and on July 29 we could announce that the following rights issue had been heavily oversubscribed. The rights issue provided a further SEK 29.4 million to Initiator Pharma before issue costs. I am truly impressed by and grateful for the confidence in Initiator Pharma shown by investors, led by long-term investors Linc AB and Adrigo Asset Management AB.

The successful financing meant that we could start the preparations for the clinical development of the IPTN2021 program in our new Orphan Drug indication Trigeminal Neuralgia. We are now financed to complete the ongoing clinical Phase 2a with IP2018 and clinical Phase 2b with IPED2015 for the treatment of erectile dysfunction of psychogenic and organic origin, respectively.

The medical need for a new effective treatment for ED is massive, expected to affect more than 300 million men worldwide by 2025. The drug candidates in Initiator Pharma’s IPED2015 and IP2018 clinical programs in erectile dysfunction both represent “First in Class” treatments within their indication and are expected to improve the quality of life for a growing number of patients who are not responding to, or cannot be treated with, existing drugs on the market.

IP2018 – Phase 2a

For our ongoing Phase 2a study with our monoamine reuptake inhibitor IP2018 in depressed, ED patients, where the recruitment rate has been slow due to the Covid-19 pandemic, we received approval from the regulatory authorities to modify certain inclusion criteria in order to ensure a successful completion of the trial. The amendment has enabled us to cover an even broader portion of the Psychogenic ED patient segment which will provide unique guidance for the future positioning of IP2018. We are looking forward to recruiting the remaining patients into this trial, but we are focused on only enrolling the appropriate patients for the study to maximize the value of the trial and its results.

IPED2015 – Phase 2b initiated in September

On September 24 we could announce that the first patient had been dosed in the Phase 2b study in Erectile Dysfunction (ED) patients in our IPED2015 program. The study is carried out in collaboration with MAC Clinical Research, UK, at multiple centers across UK. Results from our earlier Phase 2a Proof-of-Concept study support the goal of further developing an oral formulation of IP2015 for the treatment of moderate and severe erectile dysfunction in patients who do not respond to current therapies.

The Phase 2b IPED2015 study is a randomized, double-blind, parallel group, repeat single oral dose study of IP2015 or placebo in otherwise healthy organic Erectile Dysfunction patients. The plan is to include 120 patients in the study divided into 3 parallel arms receiving a higher (also used in the first Phase IIa study) and a lower dose of IP2015 and placebo, respectively, and treatment for 4 weeks with frequent assessments of erectile dysfunction, safety and pharmacokinetics. The aim is to report results from the study in H2 2022.

IPTN2021 – getting closer to clinical development

Trigeminal Neuralgia is a rare disease with a prevalence of 10-20 per 100,000. It is a deliberating orofacial pain condition characterized by sudden onset of an extreme, short-duration yet debilitating pain, often described as suicidal pain. The only available FDA-approved treatment for Trigeminal Neuralgia, Carbamazepine, only provides limited painrelief and is associated with a significant number of side effects. Therefore, the unmet need for a new efficacious, tolerable and safe treatment is exceptionally high. Our ambition is to develop a First-Line treatment for the Trigeminal Neuralgia patients.

Following thorough preparations, we filed our Clinical Trials Application (CTA) on October 19 to the British regulatory agency, MHRA, for the planned Phase I study in our IPTN2021 program against Trigeminal Neuralgia with the drug substance IP2015 in healthy subjects challenged with pain inducing ingredient (capsaicin). The study will provide supportive pain related efficacy, biomarker and safety information to the planned clinical development of IP2015 into relevant pain indications. The program is based on the IP2015 asset that has already been proven safe and tolerable in the IPED2015 clinical trials. When the Phase I study is completed, and given positive results, we intend to follow up with a Phase 2 trial including Trigeminal Neuralgia patients. The interaction with the regulatory authorities will provide valuable guidance for both the design of the first IPTN2021 trial in patients and for the potential subsequent registration trial. We also intend to apply for Orphan Drug Designation and subsequent Fast Track designation or conditional approval by the FDA or EMA, respectively.

NIDA-agreement on preclinical assets

Initiator Pharma targets CNS disorders with significant unmet medical needs and I am very proud of the quality and attractiveness of our clinical portfolio. And aside from our progress in our clinical programs, we could also announce in September the signing of a screening agreement with the National Institute on Drug Abuse (NIDA) in the USA in order to investigate the potential benefits of Initiator Pharma’s preclinical assets IPDP2015 and IPNP2015 for improved treatment of addiction. In this prestigious collaboration, NIDA will perform the studies at no cost to the company while Initiator Pharma will maintain all rights to the assets and to use of the data. We do also see this as yet an important validation of our assets’ broad potential in the CNS field.

Initiator Pharma – now on Nasdaq First North Growth Market

We were approved and could carry out the planned move from Spotlight Stock Market in the end of the quarter and since October 25, 2021, the Initiator Pharma share is now listed and traded on Nasdaq First North Growth Market. In connection with the change of listing venue we also launched our new and updated website. We do hope that investors will appreciate the potential of the improved visibility and increased access to the capital markets that that we expect from our new listing.

Finally, I would once more express my thanks both to old and new investors for your confidence in Initiator Pharma, highlighted by the successful capital raise in the beginning of this quarter. The future looks very exciting, and our three clinical-stage programs will all have upcoming key value inflection points in the form of Phase 2 data read-outs over the next couple of years. As always, I look forward to keeping you informed on the clinical development of our portfolio.

Copenhagen, November 19, 2021

Claus Elsborg Olesen