From Interim Report Q1 2026
May 8, 2026
Solid progress in the vulvodynia Phase IIa study
Our main clinical focus remains the ongoing randomized, placebo controlled Phase IIa study evaluating the pain-relieving effects and safety of pudafensine in women with vulvodynia. As announced on 28 April, enrolment is progressing as planned, half of the study’s 24 participants have already been dosed, and several have successfully completed the trial. Additional candidates are currently in screening.
The four-way crossover design, in which each participant receives pudafensine and placebo across separate treatment periods, enables robust and directly comparative data generation. We continue to expect topline results by the end of 2026.
Vulvodynia is a chronic neuropathic pain condition affecting approximately 10 percent of women worldwide and remains one of the most underserved pain conditions in medicine, with no approved therapies available to date. Pudafensine is well suited to this indication. Through its dual mechanism of action, it has the potential to address both the central pain component and the sexual dysfunction that characterize the condition. Our goal is to establish the first clinical proof-of-concept for a pharmacological treatment in vulvodynia – a result we believe could open a significant commercial opportunity.
Full strategic focus on pudafensine
On 17 April, we announced our decision to fully prioritize pudafensine and discontinue further development of IP2018 for psychogenic erectile dysfunction. The reasoning was straightforward: pudafensine is our strongest asset by a clear margin. It has demonstrated positive, statistically significant efficacy in a Phase IIb study in organic erectile dysfunction, shown effects in pain-related clinical testing, and is now advancing in vulvodynia. Its dual mechanism of action, targeting both pain and sexual dysfunction in a single oral molecule, is genuinely differentiated, and there is no comparable compound in development.
It is never easy to discontinue a clinical programme. But for a company of our size, focus matters. Our partnering discussions have consistently pointed in the same direction: the clearest interest, the strongest clinical rationale, and the most compelling commercial opportunity are all with pudafensine. Resources previously allocated to IP2018 will be redirected to the continued advancement of our lead asset.
Intellectual property position further strengthened
In February 2026, the European Patent Office granted our application covering pudafensine for the treatment of Female Sexual Dysfunction. Following validation, the patent provides protection across a large part of Europe through the Unitary Patent system, with additional coverage in the UK, Switzerland, Spain, Poland, Ireland and Norway.
The patent covers a broad range of conditions, including hypoactive sexual desire disorder, female sexual arousal disorder, orgasmic dysfunction, and sexual pain disorder – with vulvodynia specifically included, directly aligned with our ongoing Phase IIa programme. Together with our existing composition of matter and medical use patents, the portfolio supports exclusivity for pudafensine well into the 2040s, subject to regulatory extensions.
Business development remains a core priority
Advancing partnering discussions for pudafensine remains a central part of our agenda. The progress made in the vulvodynia study, the decision to fully commit to the asset, and a strengthened IP position all contribute to a clearer and more compelling case in these conversations. We are actively engaged with relevant potential partners and expect the clinical progress anticipated in the second half of 2026 to further support these efforts.
Looking ahead
The key priority for the remainder of 2026 is clear: complete the vulvodynia Phase IIa study and report topline data. If the results confirm pudafensine’s clinical potential in this indication, it will be a defining moment for the company, and a meaningful step toward bringing a new treatment to patients who currently have none. I would like to thank our shareholders, partners, and the team at MAC Clinical Research for their continued commitment to this work.
Copenhagen, May 8, 2026
Claus Elsborg Olesen
CEO