Ms. Samira Sakhia reports

KNIGHT THERAPEUTICS ANNOUNCES REGULATORY SUBMISSION OF GEMTESA® IN CANADA

Knight Therapeutics Inc.'s new drug submission (NDS) for Gemtesa (vibegron), proposed for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency in adults, and OAB with symptoms of urge urinary incontinence, urgency, urinary frequency and nocturia in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH), has been accepted for review by Health Canada.

"For patients living with overactive bladder, and for adult males managing OAB alongside BPH, having access to an effective treatment option can make a real difference in daily life," said Samira Sakhia, president and chief executive officer, Knight Therapeutics. "The acceptance of our submission for Gemtesa in Canada is an important step toward bringing this therapy to the patients who need it. At Knight, our commitment goes beyond building our portfolio. We are dedicated to improving access to innovative therapies that improve patient outcomes. We are also pleased to advance this milestone together with our partner, Sumitomo Pharma America Inc."

In June, 2025, Knight entered into exclusive supply and distribution agreements with Sumitomo's Pharma America (SMPA) to commercialize Gemtesa, as well as Orgovyx (relugolix) and Myfembree (relugolix/estradiol/norethindrone acetate) in Canada.

About Gemtesa

Gemtesa (vibegron) is marketed in the United States for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults and in adult males taking medication for benign prostatic hyperplasia (BPH). Gemtesa works by selectively targeting beta adrenergic receptors to reduce OAB symptoms through the relaxation of the bladder detrusor muscle to increase capacity.

Gemtesa is a registered trademark of Sumitomo Pharma Co. Ltd. All other trademarks are the property of their respective owners.

About overactive bladder

Overactive bladder (OAB) is a symptom syndrome characterized by urinary urgency, usually accompanied by increased urinary frequency and nocturia, with or without urgency incontinence, in the absence of urinary tract infection (UTI) or other obvious pathology. These symptoms are commonly associated with involuntary contractions of the detrusor muscle, although they can also result from other forms of lower urinary tract dysfunction. The pooled global prevalence of OAB was estimated at approximately 20 per cent, with prevalence higher in women (nearly 22 per cent) than in men (roughly 16 per cent). Canadian population based estimates reported in the Canadian Urological Association (CUA) guideline from May, 2017, indicate an overall prevalence of approximately 14 to 18 per cent, with prevalence increasing with age.

About benign prostatic hyperplasia

Benign prostatic hyperplasia (BPH) is a histologic diagnosis describing the proliferation of smooth muscle and epithelial cells within the prostatic transition zone, which commonly leads to enlargement of the prostate gland. In men presenting with lower urinary tract symptoms (LUTS), the symptoms are frequently presumed to arise from bladder outlet obstruction caused by the enlarged prostate. Even when the bladder outflow obstruction is relieved surgically, storage symptoms consistent with overactive bladder (OAB) may persist; detrusor overactivity has been reported in approximately 20 per cent to 40 per cent of men. LUTS are conventionally divided into storage, voiding and postmicturition symptoms. In the population-based EPIC study, storage symptoms were the most prevalent category among men (51.3 per cent), exceeding both voiding (25.7 per cent) and postmicturition (16.9 per cent) symptoms.

BPH becomes increasingly prevalent with age, and symptoms of OAB, which are often associated with BPH, are frequently misattributed to normal aging. In the United States, approximately 14 million men are living with BPH, and up to 75 per cent of these individuals experience OAB symptoms. Despite this high prevalence, OAB symptoms in men often remain unrecognized, particularly in those with underlying BPH. It is estimated that up to 80 per cent of OAB cases in men may go undiagnosed.

About the Courage trial

The Courage trial (NCT03902080; URO-901-3005) was a phase 3, multicentre, randomized, double-blind, placebo-controlled study evaluating Gemtesa 75 mg once daily versus placebo over 24 weeks in men greater than or equal to 45 years of age with symptoms of overactive bladder (OAB) who were receiving pharmacological therapy with alpha-blockers, with or without 5alpha-reductase inhibitors, for BPH. Of 1,105 participants randomized 1:1 to vibegron or placebo, 965 (87.3 per cent) completed the trial. The study met both co-primary endpoints at week 12, demonstrating statistically significant reductions from baseline versus placebo in mean daily micturitions (least squares mean difference -0.74; 95 per cent CI -1.02, -0.46; P less than .0001) and urgency episodes (-0.95; 95 per cent CI -1.37, -0.54; P less than .0001). Gemtesa also met all prespecified secondary end points, with significant reductions versus placebo in nocturia episodes and urge urinary incontinence (UUI) episodes. Adverse events occurring in greater than or equal to 2 per cent of participants were hypertension, COVID-19, UTI and hematuria.

About the Empowur trial

Empowur was a 12-week, double-blind, placebo-controlled phase 3 study evaluating vibegron 75 milligrams versus placebo in adults with OAB, as part of an extensive development program involving more than 4,000 OAB patients. The study demonstrated that treatment with Gemtesa resulted in statistically significant reductions in daily urge urinary incontinence episodes, micturition episodes and urgency episodes, as well as an increase in volume voided, compared to placebo. A long-term extension of the Empowur study was also conducted under double-blind conditions. The most common adverse reactions reported in 2 per cent or more of patients treated with Gemtesa were headache, nasopharyngitis, diarrhea, nausea and upper respiratory tract infection.

About Knight Therapeutics Inc.

Knight Therapeutics, headquartered in Montreal, Canada, is a pharmaceutical company focused on acquiring, in-licensing and commercializing pharmaceutical products for Canada and Latin America. Knight's Latin American subsidiaries operate under United Medical, Biotoscana Farma and Laboratorio LKM. Knight Therapeutics' shares trade on the Toronto Stock Exchange under the symbol GUD.

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