Mr. Craig Millian reports

HLS THERAPEUTICS PARTNERS WITH ESPERION THERAPEUTICS TO COMMERCIALIZE NEXLETOL AND NEXLIZET IN CANADA

HLS Therapeutics Inc. has entered into an agreement with Esperion Therapeutics Inc. 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 Nexlizet. 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 United States 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.

"We look forward to working with Esperion to bring these innovative treatments to the many Canadians suffering from or at risk of cardiovascular disease," said Craig Millian, chief executive officer at HLS. "Adding Nexletol and Nexlizet to the HLS product portfolio is aligned with our stated BD strategy and will strengthen our position in the Canadian cardiovascular market."

"We are pleased to partner with HLS to provide advanced cardiovascular treatment options to patients across Canada," said Sheldon Koenig, president and chief executive officer of Esperion. "HLS is highly regarded within Canada for their strong capabilities and relationships in the cardiovascular therapeutic area. This collaboration furthers Esperion's commitment to addressing cardiovascular and cardiometabolic diseases globally."

The agreement includes an upfront payment of $1-million, an additional $1-million upon Health Canada approval, customary royalties on future sales, and potential milestone payments tied to pricing and reimbursement and achievement of significant commercial sales targets. HLS will finance all upfront and milestone-based payments, along with associated launch costs, through existing cash reserves without requiring additional financing. Furthermore, the company intends to leverage current commercial infrastructure and does not anticipate a significant increase in operating expenses will be required.

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 that address unmet needs in the treatment of psychiatric disorders and cardiovascular disease. 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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