Business highlights in Q4 2025
- In November the Company announced that its Clinical Trial Application (CTA) for a planned Phase IIa clinical proof-of-concept study in women with vulvodynia had been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and a local ethics committee.
- In December the Company initiated patient enrollment in its Phase IIa clinical proof-of-concept study evaluating pudafensine in women suffering from vulvodynia. Dosing of the first patients is expected to begin in January 2026, and completion of the study is projected by the end of 2026.
Business highlights after this reporting period
- The European FSD patent (EP4551221B1) was granted 18 Feb 2026.
Financial Highlights
| Fourth Quarter (2025-10-01 – 2025-12-31) |
| Net revenue were KDKK 0 (0) |
| Operating loss, EBIT was KDKK -6,966 (-2,701) |
| Earnings per share before and after dilution was DKK -0.04 (-0.02) |
| Cash: KDKK 26,245 (13,371) |
| Solidity: 90% (97%) |
| Full year 2025 (2025-01-01 – 2025-12-31) |
| Net revenues were TDKK 0 (0) |
| Operating loss, EBIT was TDKK -17,781 (-14,502) |
| Earnings per share before and after dilution was DKK –0.20 (-0.23) |
Solidity: equity divided by assets.
The Board of Directors have decided that interim reports will be published in English only.
Link to the full report
https://www.initiatorpharma.com/en/investors/reports-and-presentations/