From Year-end report 2024
February 28, 2025
I am pleased to share an update on Initiator Pharma’s progress during the fourth quarter of 2024, a period marked by maintained focus on value creation and continued low operational costs.
Building on the momentum of the previous quarters during the year, we have accelerated our efforts on business development and strategic partnerships based on our key programs in erectile dysfunction (ED) and our expansion into pain and female sexual dysfunction (FSD).
At the beginning of last year, we announced the expansion of the company’s position to a broader Sexual Health Franchise, including both male ED and FSD indications. Both our lead drug candidates, pudafensine and IP2018, have shown significant efficacy in preclinical models for FSD, and we see a significant opportunity within this area. The commercial potential is considered very attractive, with substantial market growth anticipated in the coming years.
An analysis of the FSD commercial opportunity, executed by Global Life Sciences in the UK, has conservatively concluded that a product for underserved women suffering from FSD/HSDD (Hypoactive Sexual Desire Disorder) has the potential to reach peak sales of USD 2 billion. The expansion of our pipeline in FSD remains a key focus as we enter 2025, and we are currently evaluating indications where the market potential for an approved treatment is significant.
Supporting the uniqueness of advancing pudafensine for FSD is the fact that many women with sexual dysfunctions often suffer from vaginal pain, either generally or in connection with sexual activity. A common female-specific pain indication is vulvodynia – a severe chronic pain condition that affects the vulvar area and occurs without an identifiable cause.
In a previous randomized, double-blind, placebo-controlled study, pudafensine had a positive effect on pain and showed the same effects as in preclinical studies, providing strong support for the unique positioning of pudafensine as a novel and superior treatment for FSD.
One of the main reasons for expanding indications into the FSD area is the significant interest we see from the industry and leading players. This was evident when participating in key industry events during the fourth quarter, such as BioEurope, the Jefferies Healthcare Conference, and JP Morgan’s Annual Health Care Conference at the beginning of this year. These business development and investor-focused events have resulted in productive engagements and several fruitful meetings.
The growing recognition of our innovative approach in treating ED and FSD has led to increased interest from potential partners and investors, positioning us well for attractive collaborations and funding opportunities.
We remain poised to continue the development of pudafensine as a monotherapy for ED but also see an attractive combination opportunity with PDE5i products. Our preclinical data clearly demonstrates an additive effect of a combination, and this is also an important opportunity, as such a product would enable poor PDE5i responders and has the potential to establish itself as a premium product, differentiating itself from generic PDE5i products.
Our main focus remains on patients with moderate to severe ED – a significant medical condition affecting millions of men globally – and we have continued to make advancements in our clinical programs as we prepare for the next phase of pudafensine’s development. This includes refining our plans for Phase III studies in ED, which will be central for future regulatory approval.
Our previous Phase IIb study demonstrated both statistically and clinically relevant efficacy, reinforcing our confidence in pudafensine’s potential as a novel treatment for ED. The prolonged treatment duration in Phase III studies is expected to further validate the drug’s effectiveness and long-term benefits.
With 2024 behind us, we remain committed to advancing our clinical programs while maintaining operational efficiency and a strong focus on value creation. We are encouraged by the interest in our Sexual Health Franchise from both regional and global partners, and we are well positioned for potential collaborations that can further accelerate our growth and expand our reach.
I extend my sincere gratitude to our shareholders and stakeholders for their unwavering confidence in Initiator Pharma. Together, we are driving innovation and transforming the treatment landscape for sexual dysfunction and beyond.
Copenhagen, February 28, 2025
Claus Elsborg Olesen
CEO