CEO Letter

From Year-end Report Q4 2025

In the fourth quarter of 2025, Initiator Pharma successfully transitioned from clinical preparation to clinical execution, marking a defining milestone in the company’s development. Following the UK regulatory and ethics approval received in November, we initiated patient enrolment in our randomized, placebo-controlled Phase IIa proof-of-concept study with our lead asset pudafensine in 24 women suffering from vulvodynia, a debilitating neuropathic pain condition with no approved therapies and a substantial unmet medical need.

We have now dosed the first patients in the study, thereby formally commencing our first clinical program in vulvodynia and entering a new and highly important phase for Initiator Pharma.

Focus on Pain and Sexual Health in Both Men and Women

We remain firmly convinced of the potential of our portfolio and are highly focused on delivering strong clinical data in areas where our compounds can offer meaningful benefits to patients, with a particular focus on pain and sexual health in both men and women.

Pudafensine is a unique dopamine modulator with a differentiated dual mechanism of action, increasing central dopamine levels to alleviate pain while simultaneously addressing sexual dysfunction. No other compound in development combines these properties in a single molecule.

Importantly, pudafensine has previously demonstrated a solid safety profile in more than 100 patients dosed in clinical trials in erectile dysfunction, providing a strong foundation as we now advance into a new therapeutic indication.

First Patients Dosed in the Vulvodynia Phase IIa Study

One of our main priorities is the progress of the ongoing randomized, placebo-controlled Phase IIa study evaluating the pain-relieving effects and safety of single oral doses of pudafensine in women suffering from vulvodynia.

Following approval from UK regulatory and ethics authorities in late fall, patient enrolment is now underway, and we have already dosed the first patients. The four-way crossover design allows each participant to receive both pudafensine and placebo during separate treatment periods, enabling robust and directly comparative data generation.

Based on current recruitment expectations, we continue to anticipate reporting topline results in late 2026.

The vulvodynia study builds on the encouraging results from our previous pain challenge trial. We aim to generate first clinical proof-of-concept data in this neuropathic pain condition, establishing pudafensine as a first-in-class treatment in a field where patients currently have no approved therapeutic options.

If successful, pudafensine has the potential to become the first approved pharmacological treatment for vulvodynia. Beyond vulvodynia as a first indication, we see significant follow-on opportunities across a broad range of neuropathic pain conditions over time, supporting substantial long-term value creation.

Collaboration with MAC Clinical Research

The study is conducted in close collaboration with our UK-based partner and shareholder, MAC Clinical Research, and is primarily financed through a convertible credit agreement of up to GBP 2.5 million.

This structure continues to provide important strategic advantages, demonstrating MAC’s strong commitment and confidence in our assets while enabling capital-efficient clinical execution. MAC’s extensive experience within sexual health and pain, combined with its broad clinical site network, supports efficient patient recruitment and high-quality study conduct.

I am pleased with the strong progress achieved so far and encouraged by the operational execution of the trial.

Business Development Remains a Core Priority

In parallel with clinical execution, we continued to strengthen Initiator Pharma’s strategic positioning during the quarter and into early 2026.

In January, we were present at the J.P. Morgan Healthcare Conference in San Francisco, which remains the most important annual gathering for the global life science industry. The conference provided valuable opportunities to engage with potential partners and investors and to present our clinical strategy and portfolio, with particular focus on the vulvodynia program and our advanced erectile dysfunction assets.

Business development remains a core priority, and we are actively pursuing partnering discussions to maximize the value of our pipeline.

Strengthened and Extended IP Position

In February 2026, we further strengthened the long-term commercial foundation of Initiator Pharma through the grant of a European patent covering pudafensine for the treatment of Female Sexual Dysfunction.

This important milestone reinforces the breadth and durability of our intellectual property portfolio and underlines the innovative potential of pudafensine beyond erectile dysfunction. Strong patent protection remains a key pillar of our strategy as we advance our programs and engage in future partnering and commercialization discussions.

Looking ahead, 2026 will be a highly significant year for Initiator Pharma. With patient dosing underway in our Phase IIa vulvodynia study, continued business development activities, and a strengthened intellectual property position, we are well positioned to deliver meaningful progress and value creation.

I would like to thank our shareholders, partners, and employees for their continued support and commitment as we work toward bringing new treatment options to patients with significant unmet medical needs.

Copenhagen, February 20, 2025
Claus Elsborg Olesen
CEO