HLS Therapeutics Partners with Bayer to Commercialize VERQUVO® 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.

TORONTO, Nov. 3, 2026 /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 Bayer Inc. ("Bayer") to commercialize VERQUVO® (vericiguat) in Canada.

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 trial¹. 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 healthcare 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.² 

"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, CEO 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 fund 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 track record of success in these therapeutic areas and at managing products in each of these lifecycle stages. For more information visit: www.hlstherapeutics.com 

ABOUT BAYER

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, "Health for all, Hunger for none," the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, Bayer aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, Bayer employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, visit: www.bayer.com 

REFERENCES

1: Armstrong PW, Pieske B, Anstrom KJ, et al. Vericiguat in patients with heart failure and reduced ejection fraction. N Engl J Med. 2020;382(20):1883-1893.  
2: Heart and Stroke Foundation of Canada; hs-heart-failure-report-2022-final.pdf

FORWARD LOOKING INFORMATION

This release includes forward-looking statements regarding HLS and its business. Such statements are based on the current expectations and views of future events of HLS's management. In some cases the forward-looking statements can be identified by words or phrases such as "may", "will", "expect", "plan", "anticipate", "intend", "potential", "estimate", "believe" or the negative of these terms, or other similar expressions intended to identify forward-looking statements, including, among others, statements with respect to HLS's pursuit of additional product and pipeline opportunities in certain therapeutic markets, statements regarding growth opportunities, expectations regarding financial performance, and the NCIB and ASPP. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting HLS, including risks relating to the specialty pharmaceutical industry, risks related to the regulatory approval process, economic factors and many other factors beyond the control of HLS. Forward-looking statements and information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause HLS's actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statement or information. A discussion of the material risks and assumptions associated with this release can be found in the Company's Annual Information Form dated March 11, 2026, and Management's Discussion and Analysis dated August 11, 2026, both of which have been filed on SEDAR+ and can be accessed at www.sedarplus.ca. Accordingly, readers should not place undue reliance on any forward-looking statements or information. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and HLS undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

SOURCE HLS Therapeutics Inc.

HLS CONTACT INFORMATION: Dave Mason, Investor Relations, HLS Therapeutics Inc., [phone], [email protected]