Dicot Pharma provides an operational update

Uppsala, Sweden, September 17, 2024. Following the successful outcome of Dicot Pharma's rights issue, an operational update is being presented today. The company will continue to focus on the development of its potency drug candidate, with a phase 2a study set to commence soon. Additionally, the operational plan includes advancing R&D activities, a listing on Nasdaq First North, and initiating preclinical studies for new indications within metabolic diseases.

Dicot Pharma's rights issue in August was oversubscribed, and an over-allotment option was exercised, resulting in a total of approximately SEK 135 million before costs to the business. This gives the pharmaceutical company a strong financial position.

As the company announced in June, results from animal studies within the framework of LIB-01's research program show that the substance unexpectedly appears to influence several conditions and diseases that are commonly characterized by dysfunction in the body's metabolism. These include conditions such as obesity, diabetes, and high blood pressure.

Based on these promising results and the successful outcome of the rights issue, Dicot Pharma's board and management have conducted a strategic review, which now forms the foundation of the operational plan, where the primary focus will continue to be on the clinical development of the potency drug candidate LIB-01.

Operational update:

• A phase 2a trial is set to begin in the fourth quarter. The company remains on track with its previously communicated timeline regarding all preparations, and the clinical trial application was submitted in July 2024. The placebo-controlled trial, involving approximately 140 patients, aims to demonstrate a statistically significant effect of LIB-01 in improving erectile function in patients with erectile dysfunction.

• The company advances certain R&D activities related to upcoming development phases, including tablet development, scaling up the manufacturing process, and preparations to open an Investigational New Drug Application (IND) in the USA, which is required for conducting clinical trials there. The company will also make other important preparations required for clinical phase 2b.

• In addition to the development of the potency drug candidate LIB-01, the company´s strong financial position allows for the initiation of a preclinical development program in metabolic diseases. A comprehensive market analysis conducted by an external party on behalf of Dicot Pharma has been matched against the company´s own available results in metabolic diseases, which in total strongly justifies further research into a number of prioritized indications.

• In the fourth quarter, the company intends to apply for listing on the Nasdaq First North Growth Market, as it is assessed to support Dicot Pharma's continued development, internationalization, and competitiveness. The listing will enable a broader and more international shareholder base and is anticipated to generate increased interest in the share from stakeholders and analysts.

• In line with the business strategy for LIB-01, i.e., entering partnerships with larger pharmaceutical companies to finance and further develop the drug for the world market, the strong outcome of the rights issue puts Dicot Pharma in a favorable position. Efforts to engage with potential partners will now be intensified alongside the phase 2a study and will be carefully managed by the board and management to maximize shareholder value.

"We are in a favorable position, both financially and in terms of study results. The board and management have high ambitions for Dicot Pharma, with an innovative mindset, determination, and shareholder value as our guiding principles. Developing the next generation of potency drugs remains our core business, and thanks to the outcome of the rights issue, we now have the capacity to expand and explore new indications. We are very excited about what lies ahead", comments CEO Elin Trampe.

For further information, please contact:

Elin Trampe, CEO
Phone: +46 72 502 10 10
E-mail: [email protected]

About Dicot Pharma AB

Dicot Pharma is developing the drug candidate LIB-01, which will be a potency agent to better treat erectile dysfunction and premature ejaculation. The ambition is to create a drug with significantly longer effect and far fewer side effects, compared to current available drugs. Today, over 500 million men suffer from these sexual dysfunctions and the market is valued at USD 8 billion. Dicot's strategy is to develop LIB-01 under own auspices until phase 2a study and thereafter in partnership with larger, established pharmaceutical companies, finance and develop LIB-01 further to a registered pharmaceutical on the world market.

Dicot Pharma is listed on Spotlight Stock Market and has approximately 6,500 shareholders. For more information, please visit www.dicotpharma.com.