CEO Letter

From Interim Report January – September 2024

I am pleased to share an update on Initiator Pharma’s progress during the third quarter of 2024. We have focused on two main objectives; our business development efforts for our programs in erectile dysfunction (ED), and our expansion into pain and female sexual dysfunction (FSD). As previously communicated, FSD complements the company’s strong position within ED, and our most advanced asset, pudafensine is a clinical de-risked candidate with a novel mode of action modulating dopamine in pain while strengthening the natural sexual response. Our pre-clinical data in FSD, combined with our pre-clinical and clinical results in pain and ED strongly support pudafensine’s potential in the indication.

Early in the quarter our international patent application concerning the dosage regime for our leading drug candidate pudafensine in the treatment of ED was published as WO2024/146892. This patent application provides a strong foundation for pudafensine, extending its protection until 2044 with possibilities for further extension. The revitalization of the patent portfolio continues as we progress in exploring pudafensine’s potential as a standalone therapy or in combination with existing treatments to enhance efficacy due to its unique mechanism of action.

Erectile dysfunction is a significant medical condition affecting millions of men’s lives globally. Our goal in advancing pudafensine for the treatment of ED is to provide an effective, well-tolerated therapy that can make a meaningful difference in patients’ lives. The unique ability of pudafensine to increase central dopamine and peripheral nitric oxide release offers a new pathway for initiating and maintaining erection, setting it apart from current PDE5 inhibitors. A randomized double-blind study of 130 patients with moderate-to-severe ED with organic origin, showed statistically and clinically relevant efficacy Phase IIb data for our leading drug candidate pudafensine, clearly highlighting its potential to address a significant unmet medical need, and provides strong support for pudafensine’s further development towards market authorization.

Phase III studies are required for the registration and marketing of pudafensine for the treatment of erectile dysfunction. As shown in our Phase IIb study with four weeks treatment, the effect of pudafensine was more pronounced with time. Phase III studies are typically longer, with treatment times of 12 weeks; therefore, we are excited to anticipate that pudafensine will have an even more significant effect in forthcoming studies of longer duration. The further clinical development program for pudafensine also includes an optimized solid oral dosage form, for which we obtained positive data in 2023 demonstrating that the oral solid dosing formulations provide relevant drug bioavailability and pharmacokinetic drug release profiles.

The strong efficacy data for pudafensine in organic ED is complemented by IP2018, which has shown positive, statistically significant, and dose-dependent clinical observations related to efficacy in psychogenic ED in a Phase IIa clinical trial in 24 patients with mild to moderate ED.

We are encouraged by the interest in our Sexual Health Franchise from both regional and global partners. The growing interest in the Female Sexual Dysfunction (FSD) space, combined with the strong data we continue to generate with our assets in this area, position us well for potential collaborations that can further accelerate our growth and expand our reach.

We see a clear rationale for pudafensine in FSD, especially since it addresses the most bothersome aspects of several FSD-conditions: pain and sexual dysfunction. Pudafensine is a clinical de-risked candidate with a novel mode of action modulating dopamine in pain while strengthening the natural sexual response. Our pre-clinical data in FSD, combined with our pre-clinical and clinical results in pain and ED strongly support pudafensine’s potential. We are currently evaluating indications where, considering the number of affected women, the market potential for an approved treatment is truly massive.

Our main focus remains on patients with moderate to severe ED – a difficult-to-treat patient group that often finds current treatments inadequate – and this is where we concentrate our business development efforts for our ED assets.

As we are approaching the end of this year, we are in the midst of a season of important business development meetings such as BioEurope, Jefferies Healthcare conference in London and the JP Morgan-week in the US. The compelling datasets for our two drug candidates within ED, and also our efforts in FSD, has drawn quite a lot of attention in the market which makes us very excited about our prospects of generating substantial shareholder value.

We will move forward with the same rigour and dedication that has brought us to this point. We will maintain our focus on low costs in our operations and a focus on value creation. We are grateful for the continued, strong support from our largest shareholders, Linc, Adrigo and MAC, our CRO-partner as well as a validating and committed investor and I sincerely thank all our shareholders, partners, employees, and the entire Initiator Pharma community for their continued support. Together, we are making significant strides towards transforming the treatment landscape for sexual dysfunction and beyond.

Copenhagen, November 29, 2024

Claus Elsborg Olesen
CEO