From Interim Report Q3 2025
November 21, 2025
In the third quarter of 2025, following our successful capital raise during the summer, Initiator Pharma focused on preparing our planned randomized, placebo-controlled Phase IIa proof-of-concept study in 24 women with vulvodynia – a debilitating condition with no approved therapies and a significant unmet medical need. The clinical study, which will be conducted in the UK, received regulatory approval in early November. We have now initiated patient enrolment and aim to dose the first participants before the end of the year, with study completion anticipated by the end of 2026.
Advancing the vulvodynia Phase IIa study
We remain convinced of the potential of our portfolio and are committed to delivering strong clinical data in areas where our products can provide true patient benefit — with a particular focus on pain and sexual health in both men and women. Our lead compound, pudafensine, is a unique dopamine modulator with a dual mechanism of action. Pudafensine increases dopamine levels centrally to relieve pain, while also addressing sexual dysfunction. No other compound in development matches pudafensine’s pharmacological profile. Furthermore, and most importantly, pudafensine has been shown to have a benign safety profile in over 100 patients dosed in our clinical trials in erectile dysfunction. With the upcoming Phase IIa study in vulvodynia, we aim to generate the first clinical proof-of-concept data in this neuropathic pain condition.
Assuming pudafensine reaches the market, it would become the first approved treatment for vulvodynia, thereby creating a new therapeutic category, offering potential blockbuster sales in vulvodynia as the first indication, but follow-up opportunities within a broad range of neuropathic pain indications over time.
The trial is conducted in collaboration with our UK-based partner and shareholder, MAC Clinical Research (MAC), and is primarily financed through a convertible credit agreement of up to GBP 2.5 million. This financing has several advantages; it shows MAC´s continued support as a validating and skilled shareholder, and their trust in our assets. MAC is a large provider of CRO services, not only to biotech companies like us, but also to big pharma. MAC has operations in Northern Europe and in the US, and has true expertise in sexual health and pain, having executed a large number of clinical trials in these segments. Hence, MAC has the reach to relevant clinicians and, therefore, patient recruitment is expected to be very efficient. MAC is the largest private CRO in northern Europe, so I am both proud and pleased that we have such strong support from MAC, besides the great support we continue to receive from our largest shareholder, Linc, supporting us through an increased ownership during the capital raise this summer.
Strategic focus and portfolio progress
Our strategic focus remains, with intense business development activities to attract one or several partners for our assets. Pudafensine has already demonstrated strong efficacy as a monotherapy in a Phase IIb study in organic erectile dysfunction (ED).
Preclinical data also indicate that pudafensine, when combined with PDE5 inhibitors, has a unique complementary profile which could benefit patients who do not respond adequately to existing ED therapies. Having recently returned from BIO-EUROPE, which was held in Vienna during the first week of November, we are encouraged by the increased interest from both regional and global pharmaceutical companies in mid-stage clinical assets. Hence, we are well poised for progressing and intensifying industry discussions for both our pudafensine and our IP2018/IP2016 franchises.
Due to the potential in pain as well as in sexual health, we have broadened our industry discussions to cover companies with an interest in the pain segment as well, and we are very encouraged by the interest we obtain.
Advancing the vulvodynia Phase IIa study
Patient enrolment is now underway for our randomized, placebo-controlled Phase IIa study evaluating the pain-relieving effects and safety of single oral doses of pudafensine. The four-way crossover design allows each participant to receive both pudafensine and placebo during separate treatment periods, ensuring robust and comparative data. We aim to initiate dosing before the end of 2025 and report topline results by late 2026. This study builds on the encouraging results from our previous pain challenge trial and could establish pudafensine as a first-in-class treatment in a field where patients currently have no approved therapeutic options.
Entering a new phase of growth
Initiator Pharma now enters a new and exciting phase with the launch of the vulvodynia study and acceleration and broadened scope of our partnering activities. We move forward with a solid scientific foundation, an attractive portfolio, a strong financial position, and the backing of an engaged network of collaborators and shareholders. I would like to extend my sincere thanks to all our shareholders, employees, and partners for your continued trust and dedication. Together, we are working to bring forward meaningful, effective treatments for patients with unmet needs in sexual health and pain.
Copenhagen, November 21, 2025
Claus Elsborg Olesen
CEO