Mr. Craig Millian reports

HLS THERAPEUTICS PARTNERS WITH BAYER TO COMMERCIALIZE VERQUVO IN CANADA

HLS Therapeutics Inc. has entered into an agreement with Bayer Inc. to commercialize Verquvo (vericiguat) in Canada.

• Verquvo is authorized and available in Canada, with public and private reimbursement in place.
• Verquvo is an oral treatment indicated for symptomatic chronic heart failure.
• HLS will assume responsibility for distribution, promotion and medical education support for Verquvo.
• The agreement marks HLS's entry into heart failure and strengthens the company's position in the Canadian cardiovascular market.

Verquvo has been authorized in Canada since April, 2023, and is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent heart failure decompensation event requiring hospitalization and/or IV diuretic therapy. Verquvo should be used in combination with standard-of-care therapy for heart failure. The approval was supported by the pivotal phase 3 Victoria trial. Verquvo is an oral, once-daily medication that is available in Canada today, with public and private reimbursement in place.

Under the agreement, HLS will assume responsibility for commercial and medical education activities for Verquvo in Canada, including promotion to health care professionals, distribution to wholesalers and the recording of net sales. HLS will assume these responsibilities and begin recording net sales effective from the first quarter of 2027. Bayer will continue to hold the market authorization for Verquvo in Canada, will retain responsibility for regulatory, pharmacovigilance, pricing and reimbursement matters, and will supply product to HLS.

Heart failure is a serious and growing health problem in Canada and a leading cause of hospitalization. An estimated 750,000 Canadians are living with heart failure and approximately 100,000 people are diagnosed with the condition each year.

"For Canadians living with heart failure, a worsening event that leads to hospitalization or an emergency department visit can mark a critical turning point, as it carries a high risk of further hospitalizations. Verquvo (vericiguat) is an additional treatment option, used alongside standard care for adults with symptomatic chronic heart failure and reduced ejection fraction who have stabilized after a recent hospitalization or intravenous diuretic treatment," said Dr. Justin Ezekowitz, cardiologist, University of Alberta in Edmonton and principal investigator of the Victoria trial.

"Verquvo gives us an entry into heart failure and is aligned with our stated BD strategy of adding medicines that fit our organizational capabilities," said Craig Millian, chief executive officer at HLS. "This addition builds on our cardiovascular portfolio, moves us into a new area of care and reinforces our leadership in cardiovascular medicine in Canada."

"We look forward to working together with HLS to support the continued commercialization of Verquvo in Canada," said Viktoria Friedrich, president and CEO, Bayer Canada.

HLS will pay Bayer royalties on net sales of Verquvo in Canada, along with potential one-time payments tied to the achievement of commercial milestones. HLS will finance these through existing resources.

About Verquvo (vericiguat)

Verquvo (vericiguat) is a prescription medicine authorized for sale in Canada and reimbursed across multiple public and private drug plans. Bayer will continue to hold the Canadian market authorization.

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 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.

We seek Safe Harbor.