INITIATOR PHARMA: Q4 2025 REPORT

INITRegulatory press release20.02.2026 klo 09.30

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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/

About Initiator Pharma

Initiator Pharma A/S is a Danish clinical stage emerging pharma company developing innovative drugs that target key unmet medical needs within the central and peripheral nervous system. Initiator Pharma’s pipeline consists of two clinical stage assets – pudafensine and IP2018 – and one preclinical asset. With pudafensine the company has reported positive, statistically significant and clinically relevant efficacy data in a Phase IIb clinical trial with patients suffering from ED. With IP2018 the company has reported positive, statistically significant, and dose-dependent clinical observations related to efficacy in psychogenic erectile dysfunction (ED) in a Phase IIa clinical trial of IP2018 in patients with mild to moderate ED.

Initiator Pharma is listed on Nasdaq First North Growth Market (ticker: INIT). Redeye Sweden AB is the company’s Certified Adviser. For more information, please visit www.initiatorpharma.com.