Mr. Craig Millian reports

HLS THERAPEUTICS ANNOUNCES HEALTH CANADA APPROVAL OF NILEMDO FOR THE REDUCTION OF LDL-CHOLESTEROL IN CANADIANS AT RISK OF CARDIOVASCULAR DISEASE

Health Canada has approved Nilemdo (bempedoic acid) for use in Canada and has issued a notice of non-compliance (NON) for Nexlizet (bempedoic acid and ezetimibe). HLS Therapeutics Inc. in-licensed the exclusive rights to Nilemdo and Nexlizet for the Canadian market from Esperion Therapeutics Inc. (nasdaq: ESPR) in May, 2025.

Nilemdo

Nilemdo (also known as Nexletol in the United States) is a once-daily oral therapy indicated to reduce LDL-C and the risk of major cardiovascular events in adults who require additional LDL-C lowering due to an inability to reach target levels with currently available therapies or due to statin intolerance. Cardiovascular disease is the second leading cause of death in Canada, yet many high-risk patients still cannot achieve guideline-recommended LDL-C targets. As a result, more than half a million Canadians may benefit from bempedoic acid.

Dr. George Thanassoulis, MD, MSc, FRCPC, professor of medicine (cardiology), at McGill University and a co-lead author of the Canadian Cardiovascular Society Lipid Guidelines, said: "Too many Canadians are unable to reach their LDL-C targets, even when following recommended treatments. Nilemdo (bempedoic acid) represents an important new option for these patients, including those patients who cannot tolerate statins. This therapy gives us a greater opportunity to reduce cardiovascular risk and help more patients live longer, healthier lives."

The approval is supported by data from the Clear Outcomes trial, a nearly 14,000-patient, randomized, double-blind cardiovascular outcomes study that demonstrated meaningful reduction in major adverse cardiovascular events (MACE) in patients unable to take recommended statin therapy. Nilemdo provides a novel, oral pathway for LDL-C lowering while being less likely to cause muscle-related side effects that limit statin adherence. Nilemdo can be used alone or in combination with other LDL-lowering therapies, including statins, ezetimibe and PCSK9 inhibitors.

"This approval represents a major milestone for HLS and for the many Canadians striving to better manage their cardiovascular health," said Craig Millian, chief executive officer of HLS Therapeutics. "Nilemdo strengthens our cardiovascular portfolio and, along with Vascepa, positions HLS as a leader in bringing novel oral CV medicines to the Canadian market. With the launch planned for Q2 2026, we believe that Nilemdo will play a significant role in our future growth and, importantly, this medicine will help more Canadians achieve their LDL-C goals and reduce their cardiovascular risk."

Nilemdo will be added to Health Canada's Register of Innovative Drugs and will benefit from eight years of data protection starting from its Nov. 17, 2025, approval. This period, combined with existing and pending patents, provides market exclusivity for the drug extending until 2040. The eligible patents will be added to Health Canada's Patent Register following receipt of the notice of compliance (NOC) and in accordance with Health Canada's process.

Nexlizet

For Nexlizet, HLS received a NON from Health Canada, indicating that the new drug submission had certain deficiencies following initial review. Health Canada did not raise any concerns regarding the clinical data, efficacy or safety profile of Nexlizet but indicated that further clarification and additional data addressing CMC (chemistry, manufacture and controls) and biopharmaceutics matters are required to support approval.

Mr. Millian added: "We are excited to launch Nilemdo in Canada in the second quarter of 2026. With support from our partner Esperion, we are working on addressing the outstanding regulatory requirements for Nexlizet and will respond to Health Canada as expeditiously as possible. Nexlizet is currently approved and marketed successfully in the U.S., Europe and other global markets, and we look forward to making this important therapy available to Canadians in the future."

About HLS Therapeutics Inc.

Formed in 2015, HLS is a pharmaceutical company focused on the acquisition and commercialization of late-stage development, commercial stage promoted and established branded pharmaceutical products in the North American markets. HLS's focus is on products targeting the central nervous system and cardiovascular therapeutic areas. HLS's management team is composed of seasoned pharmaceutical executives with a strong record of success in these therapeutic areas and at managing products in each of these life cycle stages.

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