From Interim Report Q2 2025
August 22, 2025
The second quarter of 2025 was a pivotal period for Initiator Pharma as we executed key strategic steps to reinforce our position as a leading pharmaceutical company in sexual health and pain. With a clear focus on unlocking the full potential of pudafensine, we decided to advance our most mature clinical asset in vulvodynia, a severe neuropathic pain indication with significant unmet medical needs. In addition, we also have data showing that pudafensine, when combined with PDE5 inhibitors, could offer additional benefit to patients who do not respond adequately to standard treatments for erectile dysfunction. Hence, we have decided to develop this combination further and create a platform opportunity for a future partner within erectile dysfunction.
We are convinced in the prospects of our portfolio and committed in delivering strong clinical data in segments where our products can make a true difference and create patient benefit in men and women, with a priority on both pain and sexual health. Hence, we are grateful for the continued support from our specialist investors Linc as well as from MAC, which both increased their ownership in Initiator Pharma in this capital raise, despite a challenging capital market environment. We are reassured that this financing is a key building block to create substantial value to our shareholders. It sets the foundation for partnership ahead of late clinical development and launch of our assets in both neuropathic pain and sexual dysfunction, in men as well as in women.
Our lead drug candidate, pudafensine, has previously demonstrated strong monotherapy efficacy in a Phase IIb trial in organic erectile dysfunction (ED), laying the foundation for a future late-stage clinical program. In addition, we also have preclinical data showing that pudafensine, when combined with PDE5 inhibitors, could offer additional benefit to patients who do not respond adequately to standard treatments. As a consequence, we have decided to explore this opportunity with high priority.
Additionally, IP2018, our second clinical-stage asset, has previously shown positive, statistically significant, and dose-dependent clinical observations related to efficacy in psychogenic ED. Finally, in our portfolio we have follow-up preclinical assets (IP2016) targeting neuropathic pain. Given the huge issues with opioids and the unmet medical needs in this segment, there is great interest from big pharma for clinical as well as pre-clinical stage assets of relevance, and IP2016 with its unique profile and strong patent position is just that.
Pudafensine and IP2018 offer therapeutic potential in both men and women. We see a compelling opportunity to broaden the scope for pudafensine to also include treatment of female sexual dysfunction and pain conditions in women. Preclinical models have shown promising effects in indications such as hypoactive sexual desire disorder (HSDD) and vulvodynia – a chronic and often debilitating condition affecting up to 10 percent of women globally. The data we have generated so far, together with the significant commercial potential, has strengthened our conviction to advance in this space.
In May, we announced the expansion of our Female Sexual Dysfunction (FSD) program to include vulvodynia.
Pudafensine’s dual activity profile uniquely positions it to address both pain and sexual dysfunction, two key components of this underdiagnosed condition. A randomized, placebo-controlled Phase IIa proof-of-concept study in 24 women with vulvodynia, assessing the pain-relieving effects and safety of single oral doses of pudafensine, is planned to start in the second half of this year with first results expected by the end of 2026. This study builds on encouraging results from our earlier pain challenge trial and could position pudafensine as a first-in-class treatment in an area with no approved therapies to date.
The vulvodynia study will be conducted in collaboration with our UK-based partner and shareholder, MAC Clinical Research, and primarily financed through a convertible credit agreement worth up to GBP 2.5 million. Their commitment to fund the study, along with the right to convert the credit into shares at a premium, reflects strong belief in pudafensine’s scientific and commercial promise and is a clear endorsement of our long-term strategy.
To further strengthen our financial position, improve our negotiation power in relation to business development discussions with partners, and ensure continuity across development programs, we launched a rights issue in June. The outcome, announced in early July, showed solid support from existing shareholders, including Linc and MAC, which both increased their ownership, and new investors. The issue was subscribed to approximately 86 percent and will provide net proceeds of SEK 43.3 million. These funds will enable us to advance pudafensine in vulvodynia, progress additional preclinical studies, further explore its use in combination with PDE5 inhibitors in ED, and to continue business development activities enabling new strategic collaborations that can accelerate our progress – all while securing funding well into 2027.
We are grateful for the continued support and confidence from our investors. Our commitment to value-driven development remains firm. ED is a widespread medical issue affecting millions of men globally and I am encouraged by the advancements we are making as we prepare for the next phase of pudafensine’s development in ED/FSD as well as in Vulvodynia/Pain. These opportunities are validated by a growing interest from potential partners and stakeholders.
Looking ahead, our priorities for the second half of the year include the launch of the vulvodynia trial with MAC and accelerating business development activities. We enter this next phase with a solid scientific foundation, a strong financial position, and the backing of an engaged network of collaborators and investors.
I want to thank all our shareholders, employees, and partners for your continued trust and dedication. Together, we are working to bring forward meaningful, effective treatments to patients with unmet needs in sexual health and pain.
Copenhagen, August 22, 2025
Claus Elsborg Olesen
CEO