HLS Therapeutics Agrees With Esperion Therapeutics To In-License And Commercialize NEXLETOL And NEXLIZET In Canada

– These cardiovascular medicines have the potential to address a significant unmet medical need for over half a million Canadians

– HLS will leverage existing organizational capabilities and commercial infrastructure

– Already approved and commercially available in the U.S. and Europe, NEXLETOL/NEXLIZET are under regulatory review in Canada with a decision expected later this year

– Deal terms include $1 million paid upfront and additional milestone payments tied to achievement of regulatory, pricing, reimbursement and commercial sales objectives

TORONTO, May 8, 2025 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX:HLS), a pharmaceutical company focused on addressing unmet needs in the treatment of psychiatric disorders and cardiovascular disease, announces that it has entered into an agreement with Esperion Therapeutics Inc. ("Esperion") (NASDAQ:ESPR) to in-license and commercialize NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) in Canada. All financial figures are in U.S. dollars unless otherwise stated.

In Q4 2024, Esperion submitted New Drug Submissions to Health Canada for both NEXLETOL and NEXLIZET1. Under this agreement, HLS will be responsible for obtaining Health Canada approval, which is expected by the end of 2025. NEXLETOL and NEXLIZET are oral medications currently available in the U.S. and several European countries. Initially approved by the U.S. Food and Drug Administration in 2020 to help reduce low-density lipoprotein cholesterol ("LDL-C") levels, their labels were expanded in 2024 to include broader indications for cardiovascular risk reduction in patients who are unable to take recommended statin therapy, supported by data from the CLEAR Outcomes trial.

Current estimates suggest there are over half a million Canadians who could potentially benefit from NEXLETOL or NEXLIZET. This includes patients with elevated LDL-C levels and who are either statin intolerant or who are not at their LDL-C goal despite being on combination therapy with statins and ezetimibe.