Urovant Sciences Presents Positive Pivotal Data for Vibegron During Plenary Session at American Urological Association Annual Meeting

• Pivotal Phase 3 EMPOWUR study met both co-primary endpoints, with
  significant reduction in daily urge urinary incontinence episodes and
  micturitions, compared to placebo (p<0.0001 and p<0.001,
  respectively), and a favorable safety and tolerability profile
• Efficacy observed at week 2 and maintained through week 12 in
  co-primary endpoints
• Data showed once-daily 75 mg dose has potential to be an
  efficacious agent for disruptive overactive bladder symptoms for broad
  base of patients

IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Urovant Sciences (Nasdaq: UROV), a clinical-stage
biopharmaceutical company focused on developing and commercializing
innovative therapies for urologic conditions, today announced Dr. David
Staskin presented positive, Phase 3 pivotal data demonstrating safety
and efficacy of vibegron during a plenary session at the 2019 American
Urological Association Annual Meeting (AUA) in Chicago yesterday
afternoon. Vibegron is an investigational novel, once-daily oral beta-3
adrenergic agonist being evaluated as a treatment for adults with
symptoms of overactive bladder (OAB). Dr. Staskin, a leading urologist
with St. Elizabeth’s Medical Center, and an Associate Professor of
Urology at Tufts University School of Medicine in Boston, is a key
investigator for vibegron.

Data from EMPOWUR – an international double blind, placebo-controlled,
multicenter Phase 3 clinical trial evaluating the efficacy and safety of
a once-daily 75 mg dose of vibegron – showed statistical significance
over placebo in both reduction in daily urge urinary incontinence (UUI)
episodes (p<0.001) and reduction in daily micturitions (p<0.001). The
difference compared to placebo was statistically significant as early as
week 2 for UUI and micturitions (p<0.001 and p<0.001, respectively) and
statistically significant efficacy was maintained at all timepoints
measured through the end of the study. In addition, vibegron met all
seven key secondary endpoints, including a clinically meaningful
reduction in daily urgency episodes and volume voided versus placebo.

A patient subset-analysis of the data were also included in the plenary
presentation at AUA, showing vibegron reduced UUI and micturitions in
patients previously treated for OAB symptoms with an anticholinergic or
mirabegron, the only currently marketed beta-3 agonist.

“There is a need for a new treatment option with rapid onset in a
once-daily, convenient dose for patients suffering from OAB symptoms,”
said Dr. Staskin. “The EMPOWUR data suggests that vibegron, if approved,
could be suitable for a large base of patients.”

Urovant intends to file a New Drug Application (NDA) with the U.S. Food
and Drug Administration (FDA) by early 2020.

About EMPOWUR

EMPOWUR is an international randomized, double-blind placebo- and active
comparator controlled clinical trial evaluating the safety and efficacy
of investigational vibegron in men and women with symptoms of overactive
bladder, including frequent urination, sudden urge to urinate, and urge
incontinence or leakage. A total of 1,518 patients were randomized
across 215 study sites into one of three groups for a 12-week treatment
period with a four-week safety follow-up period: vibegron 75 mg
administered orally once daily; placebo administered orally once daily;
or tolterodine ER 4 mg administered orally once daily. Additionally, 507
patients who completed the EMPOWUR trial were enrolled in a 40-week
double-blind extension study to evaluate the safety and efficacy of
longer-term treatment. The co-primary endpoints of the EMPOWUR study
are: change from baseline in the average number of micturitions per 24
hours; and change from baseline in the average number of urge urinary
incontinence (UUI) episodes per 24 hours in patients who have an average
of one or more UUI episodes per day prior to treatment. Secondary
endpoints included changes in the frequency of urinary urgency episodes
and incontinence episodes, and self-reported quality of life scores.

About Overactive Bladder

Overactive bladder (OAB) is a clinical condition characterized by the
sudden urge to urinate that is difficult to control (urgency), with or
without accidental urinary leakage (urge urinary incontinence), and
usually with increased frequency of urination. The exact cause is
unknown, making this a difficult condition to treat. In the United
States, more than 30 million people over the age of 40 suffer from the
bothersome symptoms of OAB¹, which can lead to depression,
anxiety and a negative impact on quality of life.²

About Urovant Sciences

Urovant Sciences is a clinical-stage biopharmaceutical company focused
on developing and commercializing innovative therapies for urologic
conditions. Urovant’s lead product candidate, vibegron, is an oral,
once-daily, small molecule beta-3 agonist being evaluated for the
treatment of OAB with symptoms of urge urinary incontinence, urgency,
and urinary frequency; for OAB in men with benign prostatic hyperplasia;
and for abdominal pain associated with irritable bowel syndrome. Urovant
has licensed global rights, excluding Japan and certain Asian
territories, for the development and commercialization of vibegron.
Urovant’s second product candidate, URO-902, is a novel gene therapy
being developed for patients with OAB who have failed oral
pharmacological therapy. Urovant intends to develop treatments for
additional urologic diseases. For more information, please visit www.urovant.com.

Forward-Looking Statements

This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements include all statements that are not
historical statements of fact and statements regarding the Company’s
intent, belief or expectations and can be identified by words such as
“anticipate,” “believe,” “can,” “continue,” “could,” “estimate,”
“expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,”
“plan,” “potential,” “predict,” “project,” “should,” “strive,” “to be,”
“will,” “would,” or the negative or plural of these words or other
similar expressions or variations, although not all forward-looking
statements contain these identifying words. In this press release,
forward-looking statements include, but are not limited to, statements
regarding the Company’s plans and strategies for the development and
commercialization of innovative therapies, including vibegron, for the
treatment of urological conditions.

The Company’s forward-looking statements are based on management’s
current expectations and beliefs, and are subject to a number of risks
and uncertainties that could lead to actual results differing materially
from those projected, forecasted or expected. Although the Company
believes that the assumptions underlying these forward-looking
statements are reasonable, they are not guarantees and the Company can
give no assurance that its expectations will be attained. Factors that
could materially affect the Company’s operations and future prospects or
which could cause actual results to differ materially from expectations
include, but are not limited to the risks and uncertainties listed in
the Company’s filings with the United States Securities and Exchange
Commission (SEC), including under the heading “Risk Factors” in the
Company’s Quarterly Report on Form 10-Q filed with the SEC on February
14, 2019, as such risk factors may be amended, supplemented or
superseded from time to time by other reports the Company files with the
SEC. You should not place undue reliance on the forward-looking
statements in this press release, which speak only as of the date
hereof, and, except as required by law, the Company undertakes no
obligation to update these forward-looking statements to reflect events
or circumstances after the date of such statements.

^1. Coyne, et al., EpiLUTS 2007
^2. Kinsey
D, et al., J Health Psychol. 2016

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