Lipigon Pharmaceuticals presents top-line data from the Phase II clinical trial of Lipisense in patients with elevated blood lipid levels

The study included 23 patients with moderate to severe hypertriglyceridemia, of whom 22 completed the study's first follow-up period. 12 patients were treated with Lipisense^® and 10 patients with placebo. The patients were treated with four weekly doses and then followed for 12 weeks. Additional data from the study will be generated during 2026, including the results from a long-term follow-up of all patients, 6 months after the last treatment.

Primary endpoints

The results show that the study met its primary endpoint, as the treatment demonstrated good safety and was well tolerated, with no serious treatment-related adverse events.

Additional endpoints

The study has also evaluated various efficacy parameters. The results show:

• No clinically relevant reduction in triglyceride levels and no statistically significant difference between the treatment group and placebo.
• A trend toward decreased insulin resistance, according to HOMA-IR, in the treatment group.
• No clinically relevant reduction in remnant cholesterol levels and no statistically significant difference between the treatment group and placebo.

Complete results from the phase II study are expected during 2026.

"The project is based on robust preclinical and epidemiological data pointing toward the link between both the genetic and experimental reduction of ANGPTL-4 and harmful blood lipids. The results from the phase II study are therefore a disappointment. Even if the study is small and its primary endpoint is to evaluate Lipisense^® safety and tolerability, we had hoped to observe significant effect signals. We will now conduct in-depth analyses to fully understand the outcome and to evaluate the path forward for the project," comments Johan Liwing, CEO, Lipigon Pharmaceuticals.

For further information, please contact:

Johan Liwing, Chief Executive Officer, Lipigon Pharmaceuticals

Email: [email protected]

Phone: +46 (0)70 - 670 36 75

This information is information that Lipigon Pharmaceuticals AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above on 3 December 2025 at 18:55 CET.

About the Phase II study

The randomized, placebo-controlled study included a total of 23 patients with moderate to severe hypertriglyceridemia. The patients were treated once a week for one month, for a total of four treatment sessions. They were then followed for three months after the final treatment. An additional long-term follow-up is being conducted for all patients six months after the last treatment. The primary objective of the study is to evaluate treatment safety and tolerability in patients with moderately to severely elevated blood lipid levels - hypertriglyceridemia and severe hypertriglyceridemia, respectively. The study also evaluates early signals of treatment efficacy on the blood lipid markers triglycerides and remnant cholesterol, as well as insulin resistance.

Lipigon Pharmaceuticals

Lipigon Pharmaceuticals develops lipid-lowering drugs. The company's most advanced drug candidate, Lipisense^®, reduces the levels of major blood lipids by removing the protein ANGPTL-4, which otherwise inhibits the breakdown of blood lipids. Lipisense^® is currently being evaluated in a Phase II clinical study in patients with elevated blood lipids. In addition to safety and tolerability, the study aims to evaluate Lipisense^®'s effect on triglyceride and cholesterol levels - two blood lipids that, at elevated levels, can lead to serious cardiovascular diseases. Lipisense^® is being developed in collaboration with Leaderna Therapeutics, which holds the rights to the Chinese market. Lipigon aims to establish a global licensing agreement for Lipisense^®. The company's share (LPGO) is listed on Nasdaq First North Growth Market. Certified Adviser: Redeye AB.