Mr. Craig Millian reports

HLS THERAPEUTICS ANNOUNCES NILEMDO (BEMPEDOIC ACID) IS NOW AVAILABLE IN CANADA FOR THE REDUCTION OF LDL-CHOLESTEROL IN PATIENTS AT RISK OF CARDIOVASCULAR DISEASE

HLS Therapeutics Inc. has commercially launched Nilemdo (bempedoic acid) in Canada. Nilemdo is available by prescription nationally. HLS in-licensed the exclusive rights to Nilemdo and Nexlizet (bempedoic acid and ezetimibe) for the Canadian market from Esperion Therapeutics Inc. in May, 2025.

Health Canada approved Nilemdo in November, 2025. Nilemdo is indicated to reduce low-density lipoprotein cholesterol and the risk of major cardiovascular events in adults who require additional low-density lipoprotein cholesterol 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. HLS estimates that more than half a million Canadians may benefit from Nilemdo.

"Despite considerable evidence and guideline recommendations, too many Canadians are still not reaching their LDL-C targets," said Dr. Lawrence Leiter, professor of medicine and nutritional sciences at the University of Toronto. "Bempedoic acid (Nilemdo) offers a new option for Canadian patients who cannot achieve their LDL-C goal or are intolerant to statins. We now have a well-tolerated, once-daily oral therapy that is supported by strong clinical evidence including the large Clear Outcomes trial, that provides clinicians and their patients with a new means of reducing cardiovascular risk."

A novel mechanism addressing a large unmet need

Nilemdo provides a novel, oral pathway for LDL-C lowering while being less likely to cause muscle-related side effects that limit statin adherence for many patients. In clinical practice, physicians typically initiate therapy with a statin, and then add ezetimibe if additional LDL-C lowering is needed. Nilemdo fits directly into this established treatment paradigm, providing a meaningful step-up option for patients who remain above their LDL-C target on combination therapy or who cannot tolerate adequate statin doses. Nilemdo can be used alone or in combination with other LDL-lowering agents, including statins, ezetimibe and PCSK9 inhibitors.

The approval of Nilemdo is supported by the Clear Outcomes trial, a landmark randomized, double-blind cardiovascular outcomes study in nearly 14,000 patients with high cardiovascular risk who were unable to take recommended statin therapy. The trial demonstrated that bempedoic acid significantly reduced the risk of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and coronary revascularization.

"With the launch of Nilemdo, Canadians who have been unable to reach their LDL-C targets now have a new oral treatment option supported by robust cardiovascular outcomes data," 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 cardiovascular medicines to the Canadian market. Importantly, we believe this medicine will help more Canadians achieve their LDL-C goals and reduce their cardiovascular risk."

Nilemdo has been submitted for reimbursement under private and public plans, and is currently under review. HLS is expecting meaningful private payer coverage in second quarter and potential for public reimbursement in late 2026.

Looking ahead: Nexlizet

HLS is also advancing its regulatory submission for Nexlizet (bempedoic acid and ezetimibe), a once-daily combination pill that combines two complementary LDL-lowering mechanisms. Nexlizet demonstrated approximately 38-per-cent LDL-C reduction in clinical trials. HLS is working with its partner Esperion Therapeutics Inc. to respond to Health Canada's outstanding requirements as expeditiously as possible and anticipates a 2027 commercial launch.

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.

We seek Safe Harbor.