From Interim Report January – March 2024
May 10, 2024
I am delighted to provide an update on Initiator Pharma’s progress and achievements during the start of 2024, building upon previous year’s successes where we achieved multiple important milestones across our development pipeline. We have continued to advance our goal of progressing novel drug candidates toward the market in a cost and time effective way, for the benefit of both patients in need of improved medical therapies and for our shareholders, while also strengthening our position in the market.
In 2023, we witnessed significant milestones across our development pipeline, with our programs making remarkable progress. Notably, the statistically significant and clinically relevant efficacy Phase IIb data presented in the fall for our leading drug candidate pudafensine in organic erectile dysfunction (ED) marked a pivotal achievement, highlighting its potential to address a significant unmet medical need. The clear efficacy results in moderate and severe ED support for pudafensine’s further development towards market authorization. The further clinical development program 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.
These clinical achievements were further reinforced by the recent publication of our preclinical pharmacology results in the prestigious British Journal of Pharmacology, validating the mechanism of action and strengthening our belief in pudafensine as a novel treatment for patients who do not respond to or tolerate the currently marketed drugs. Initiator’s other clinical asset, IP2018 is being developed for psychogenic ED. In the summer of 2023 we reported 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.
Our commitment to advancing sexual health extends beyond ED, as evidenced by our strategic decision to expand our focus to include Female Sexual Dysfunction (FSD). Based on promising preclinical data, we have conducted a comprehensive review, and at the beginning of the quarter, we announced our decision to build upon the success of our ED programs to establish a broader Sexual Health Franchise encompassing both ED and FSD indications. FSD includes a range of issues, such as hypoactive sexual desire disorder (HSDD, low libido), difficulty achieving arousal, pain during intercourse, and inability to reach orgasm.
This strategic move reflects our commitment to addressing unmet medical needs and presents significant revenue and earnings potential. An analysis of the commercial assessment has concluded that a product for underserved women suffering from FSD/HSDD should have the potential to reach peak sales of at least USD 2 billion. We are initially exploring the opportunity with a priority on postmenopausal women with FSD, where there currently is no available treatment option. Both Pudafensine and IP2018 could offer the potential to be a first-line treatment options in the targeted market segments.
In addition to our clinical advancements, I am pleased to announce that we welcomed MAC Clinical Research as a new shareholder in February 2024.
The background is the convertible loan agreement that was an important part of the financing of the pudafensine Phase IIb study, which was carried out by MAC. The agreement gave MAC the right to convert the credit into Initiator shares up to approximately 23 MSEK at a share price of 7.5 SEK, equivalent to a premium of more than 70 percent, upon the full completion of the study. MAC’s support further validates the potential of our programs and reinforces our confidence in the promising future ahead.
Looking ahead, we remain committed to optimizing shareholder value and pursuing strategic partnerships to further accelerate our growth trajectory. Continued discussions and negotiations with potential partners are of highest priority during 2024. With sufficient funding secured well into 2025, we are well-positioned to execute on our strategic priorities and drive value creation for our shareholders.
I would like to express my gratitude to our shareholders, partners, employees, and the broader Initiator Pharma community for their continued support and dedication. Together, we are making meaningful strides towards advancing healthcare and improving patient outcomes.
Copenhagen, May 10, 2024
Claus Elsborg Olesen
CEO