Urovant Sciences Reports Financial Results for the Second Fiscal Quarter Ended September 30, 2018 and Provides Corporate Update

BASEL, Switzerland & IRVINE, Calif.–(BUSINESS WIRE)–Nov. 12, 2018– Urovant Sciences Ltd. (Nasdaq: UROV),a clinical-stage biopharmaceutical company focused on developing therapies for urologic conditions, today reported financial results for the three and six months ended September 30, 2018 and announced corporate updates.

Recent Business Highlights

  • Completed enrollment in international Phase 3 trial for vibegron in adults with symptoms of overactive bladder (OAB) as defined by urge urinary incontinence, urgency, and urinary frequency
  • Positive results from the international Phase 2b study for vibegron in adults with OAB recently published in European Urology, the peer-reviewed medical journal of the European Association of Urology
  • Expect to initiate U.S. clinical program for vibegron for pain associated with irritable bowel syndrome (IBS) in women before year end
  • Submitted draft clinical trial protocol to the FDA to study vibegron in men with overactive bladder who have benign prostatic hyperplasia (BPH)
  • Licensed hMaxi-K, a novel gene therapy for overactive bladder
  • Completed initial public offering in October 2018 raising total gross proceeds of approximately $144.2 million

“Urovant Sciences advanced several clinical programs for vibegron, an investigational beta-3 adrenergic agonist, demonstrating our commitment to urology,” said Keith A. Katkin, chief executive officer of Urovant. “We successfully enrolled more than 1,500 patients into our robust international Phase 3 trial evaluating the safety and efficacy of vibegron as a treatment for adults with symptoms of overactive bladder. We expect to report top-line data from this phase 3 study by the end of March 2019. In addition, we plan to initiate a Phase 2a study of vibegron in women with IBS-associated pain by the end of 2018. And finally, we had productive discussions with the FDAthat culminated in us submitting a proposed protocol to study vibegron for men with overactive bladder with BPH.”

“I am immensely proud of my team’s momentum with vibegron,” added Katkin. “We also continue to assess business development opportunities that support our longer-term vision of becoming a leading urology company. We were pleased to have recently added the gene therapy hMaxi-K to our clinical development portfolio.”

Second Quarter Financial Summary

For the quarter ended September 30, 2018, research and development expenses were $20.7 million and general and administrative expenses were $3.7 million. Cash used in operations was $23.6 million for the quarter ended September 30, 2018. Net loss for the quarter ended September 30, 2018 was $24.6 million, or $1.23 per share.

Six Months Financial Summary

For the six months ended September 30, 2018, research and development expenses were $48.0 million and general and administrative expenses were $7.8 million. Cash used in operations was $44.3 million for the six months ended September 30, 2018. Net loss for the six months ended September 30, 2018 was $55.9 million, or $2.79per share.

Note to Investors

As previously announced, Urovant will hold a conference call to discuss fiscal 2018 second quarter financial results today, November 12, 2018, beginning at 1:30 p.m. Pacific Time. You can listen to this call by dialing (866) 470-1049 for domestic callers or (409) 217-8245 for international callers and entering passcode 7067348. A replay of the call will be available approximately four hours after the call and accessible for 7 days at (855) 859-2056, conference ID 7067348. A webcast will be archived on the Investor Relations page of the Urovant Sciences website immediately after the call and available for at least 30 days.

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. Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant’s second product candidate, hMaxi-K, 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 for the treatment of urological conditions; the reporting of top-line data from its phase 3 study of vibegron in adults with symptoms of OAB by the end of March 2019; the Company’s plan to initiate a Phase 2a study of vibegron in women with IBS-associated pain by the end of 2018; and the Company’s expectations regarding its clinical programs for vibegron and gene therapy hMaxi-K.

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 Company’s limited operating history and the fact that it has never generated any product revenue; the Company’s ability to achieve or maintain profitability in the future; the Company’s dependence on the success of its lead product candidate, vibegron; the Company’s reliance on its key scientific, medical or management personnel and on certain affiliates to provide certain services to the Company; risks related to clinical trials, including uncertainties relating to the success of the Company’s clinical trials for vibergron and hMaxi-K and any future therapy or product candidates; uncertainties surrounding the regulatory landscape that governs gene therapy products; the Company’s dependence on Merck Sharp & Dohme Corp. and Ion Channel Innovations, LLC to have accurately reported results and collected and interpreted data related to vibegron and hMaxi-K prior to the Company’s acquisition of the rights related to these product candidates; reliance on third parties to conduct, supervise and monitor the Company’s clinical trials; reliance on a single supplier for the enzyme used to manufacture vibegron; the ability to obtain, maintain and enforce intellectual property protection for the Company’s technology and products; risks related to significant competition from other biotechnology and pharmaceutical companies; the failure to achieve the market acceptance necessary for commercial success for a product candidate; the Company’s ability to satisfy future funding needs on commercially reasonable terms and conditions if at all; and other 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 final prospectus dated September 26, 2018 filed with the SEC on September 27, 2018, 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.

UROVANT SCIENCES LTD.
Condensed Consolidated Statements of Operations

(unaudited; in thousands, except share and per share data)

Three Months Ended
September 30,

Six Months Ended
September 30,

2018 2017 2018 2017
Operating expenses:
Research and development(1) $ 20,664 $ 4,751 $ 48,009 $ 7,883
General and administrative(2) 3,664 219 7,788 553
Total operating expenses 24,328 4,970 55,797 8,436
Other income (expense):
Other income (expense) (309) 59 (80) (88)
Loss before provision for income taxes (24,637) (4,911) (55,877) (8,524)
Provision for income taxes 5 2 60 4
Net loss $ (24,642) $ (4,913) $ (55,937) $ (8,528)
Net loss per common share—basic and diluted $ (1.23) $ (0.25) $ (2.79) $ (0.60)
Weighted average common shares outstanding—basic and diluted 20,025,098 20,025,098 20,025,098 14,240,070
(1) Includes $293 and $854 of share-based compensation during the three months ended September 30, 2018 and 2017, respectively, and $565 and $1,693 of share-based compensation expense during the six months ended September 30, 2018 and 2017, respectively.
(2) Includes $696 and $33 of share-based compensation during the three months ended September 30, 2018 and 2017, respectively, and $1,230 and $78 of share-based compensation expense during the six months ended September 30, 2018 and 2017, respectively.
UROVANT SCIENCES LTD.
Condensed Consolidated Balance Sheets

(unaudited; in thousands, except share and per share data)

September 30, 2018 March 31, 2018
Assets
Current assets:
Cash $ 1,659 $ 7,194
Prepaid expenses and other current assets 11,757 5,196
Deferred initial public offering costs 2,201
Total current assets 15,617 12,390
Property and equipment, net 587 510
Other assets 84 84
Total assets $ 16,288 $ 12,984
Liabilities and Shareholder’s Equity (Deficit)
Current liabilities:
Accounts payable $ 5,084 $ 833
Accrued expenses 9,875 3,595
Due to Roivant Sciences Ltd. 8,056 1,482
Total liabilities 23,015 5,910
Total shareholder’s equity (deficit) (6,727) 7,074
Total liabilities and shareholder’s equity (deficit) $ 16,288 $ 12,984

Source: Urovant Sciences Ltd.

Urovant Sciences Ltd.
Investor inquiries: Investors@Urovant.com
Media inquiries: Media@Urovant.com

Urovant Sciences Completes Patient Enrollment in Phase 3 Pivotal Trial Studying Vibegron for Overactive Bladder

  • More than 1,500 patients enrolled in international Phase 3 clinical trial EMPOWUR, exceeding recruitment target
  • Top-line efficacy and safety data from Phase 3 trial expected by the end of March 2019

BASEL, Switzerland & IRVINE, Calif.–(BUSINESS WIRE)–Nov. 8, 2018– Urovant Sciences (Nasdaq: UROV), a clinical-stage biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced it completed enrollment in its international Phase 3 clinical trial, EMPOWUR, evaluating the safety and efficacy of vibegron as a treatment for adults with symptoms of overactive bladder. Vibegron is an investigational oral beta-3 adrenergic agonist.

“I am proud of the progress made since initiating our robust EMPOWUR clinical trial in March of 2018,” said Dr. Cornelia Haag-Molkenteller, Chief Medical Officer of Urovant. “Exceeding our enrollment ahead of schedule underscores the interest in this trial and reinforces the need for this significantly underserved patient population.”

EMPOWUR is a randomized, double-blind placebo- and active comparator controlled clinical trial in men and women with symptoms of overactive bladder, including frequent urination, sudden urge to urinate, and urge incontinence or leakage. Top-line efficacy and safety data are anticipated by the end of March 2019.

A total of 1,530 patients who met the enrollment criteria were randomized across 216 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, the first 507 patients who completed the EMPOWUR trial have been enrolled in a 40-week double-blind extension study to evaluate the safety 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 in all patients
  • Change from baseline in the average number of urge urinary incontinence (UUI) episodes per 24 hours in patients who have one or more UUI episodes per day prior to treatment

Vibegron, which has been widely studied and recently received regulatory approval in Japan, is investigational in the United States and has not been approved by the U.S. Food and Drug Administration. Vibegron has previously been evaluated in multiple clinical trials with more than 2,600 OAB patients, including a completed international randomized, double-blind, placebo-controlled Phase 2b study with more than 1,300 subjects.

In 2017, Urovant licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant initiated EMPOWUR, its international Phase 3 clinical trial for vibegron, in March 2018.

About Overactive Bladder

Overactive bladder 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. Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant’s second product candidate, hMaxi-K, 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 for the treatment of urological conditions and the Company’s expectations regarding its clinical programs for vibegron.

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 Company’s limited operating history and the fact that it has never generated any product revenue; the Company’s ability to achieve or maintain profitability in the future; the Company’s dependence on the success of its lead product candidate, vibegron; the Company’s reliance on its key scientific, medical or management personnel and on certain affiliates to provide certain services to the Company; risks related to clinical trials, including uncertainties relating to the success of the Company’s clinical trials for vibegron and hMaxi-K and any future therapy or product candidates; uncertainties surrounding the regulatory landscape that governs gene therapy products; the Company’s dependence on Merck Sharp & Dohme Corp. and Ion Channel Innovations, LLC to have accurately reported results and collected and interpreted data related to vibegron and hMaxi-K prior to the Company’s acquisition of the rights related to these product candidates; reliance on third parties to conduct, supervise and monitor the Company’s clinical trials; reliance on a single supplier for the enzyme used to manufacture vibegron; the ability to obtain, maintain and enforce intellectual property protection for the Company’s technology and products; risks related to significant competition from other biotechnology and pharmaceutical companies; the failure to achieve the market acceptance necessary for commercial success for a product candidate; the Company’s ability to satisfy future funding needs on commercially reasonable terms and conditions if at all; and other 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 final prospectus dated September 26, 2018 filed with the SEC on September 27, 2018, 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

Source: Urovant Sciences

Urovant Sciences
Investor inquiries: Investors@Urovant.com
Media inquiries: Media@Urovant.com

Urovant Sciences to Report 2018 Second Fiscal Quarter Financial Results

BASEL, Switzerland & IRVINE, Calif.–(BUSINESS WIRE)–Nov. 5, 2018– Urovant Sciences Ltd. (Nasdaq: UROV),a clinical-stage biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced it will report 2018 second fiscal quarter financial results after the close of U.S. financial markets on Monday, November 12, 2018.

Management will host a conference call and live webcast to discuss Urovant’s financial results at 1:30 p.m. Pacific Time that same day. A question and answer session will follow management remarks.

The conference call numbers are (866) 470-1049 for domestic callers and (409) 217-8245 for international callers. The conference ID is 7067348.

A replay of the call will be available approximately four hours after the call and accessible for 7 days at (855) 859-2056, conference ID 7067348. A webcast will be archived on the Investor Relations page of the Urovant Sciences website immediately after the call and available for at least 30 days.

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. Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant’s second product candidate, hMaxi-K, 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.

Source: Urovant Sciences Ltd.

Urovant Sciences Ltd.
Investor inquiries: Investors@Urovant.com

Urovant Sciences Announces Publication of Phase 2b Data for Vibegron in European Urology

 

BASEL, Switzerland & IRVINE, Calif.–(BUSINESS WIRE)–Nov. 1, 2018– Urovant Sciences (Nasdaq: UROV), a clinical-stage biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced the publication of positive results from the international Phase 2b study of vibegron, an investigational oral beta-3 adrenergic agonist being studied for adults with symptoms of overactive bladder (OAB).

The study, which demonstrated once-daily vibegron was well-tolerated and improved OAB symptoms, was published online by European Urology, a peer-reviewed medical journal and official journal of the European Association of Urology.

The international, randomized double-blind, placebo-controlled Phase 2b study including an active comparator enrolled more than 1,300 patients with OAB symptoms including frequent urination, sudden urge to urinate, and urge incontinence (leakage). In the two-part trial, patients were first randomized to once-daily oral vibegron monotherapy (3 mg, 15 mg, 50 mg or 100 mg); tolterodine extended release (4 mg); or placebo for eight weeks. In part two, patients were randomized to monotherapy, combination therapy or placebo and received either vibegron (100 mg); tolterodine (4 mg); combination vibegron (100 mg) and tolterodine (4 mg); or placebo for four weeks.

In part one, patients randomized to vibegron 50 mg and 100 mg had clinically and statistically significant decreases in the daily number of micturitions, urgency urinary incontinence episodes, total incontinence episodes and urgency episodes at week 8, versus placebo. Moreover, as early as week 2, treatment with both vibegron 50 mg and vibegron 100 mg was associated with statistically significant decreases compared to placebo across all of these key overactive bladder endpoints. Vibegron was generally well-tolerated and there were no meaningful differences in incidence or severity of adverse events observed between the treatment groups and placebo. In part two of the study, the efficacy of vibegron monotherapy on the primary endpoint – reduction in micturitions – was statistically significant and similar to results observed in part one. The incidence of dry mouth was higher among patients treated with tolterodine alone or given concomitantly with vibegron, versus those treated with vibegron monotherapy.

In 2017, Urovant licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Earlier this year, Urovant initiated an international Phase 3 clinical program to evaluate the efficacy and safety of vibegron in adults with symptoms of OAB. Vibegron is investigational and has not been approved by the U.S. Food and Drug Administration.

About Overactive Bladder

Overactive bladder 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. Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant’s second product candidate, hMaxi-K, 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.comwww.urovant.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding Urovant’s plans to advance the clinical development of vibegron, report results of its Phase 3 clinical trial, and develop additional treatments for urologic diseases. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost, and timing of Urovant’s development activities, including the timing of the initiation and completion of clinical trials and the timing of expected regulatory filings; the clinical utility and potential attributes and benefits of vibegron, including reliance on collaboration partners and the ability to procure additional sources of financing; and our intellectual property position, including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs. Vibegron is investigational and has not been approved by the U.S. Food and Drug Administration. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled “Risk Factors” set forth in Urovant’s Registration Statement on Form S-1, which was filed with the Securities and Exchange Commission (“SEC”) and declared effective by the SEC on September 26, 2018, as well as any other future filings with the SEC available at www.sec.gov.

Given these risks and uncertainties, you should not place undue reliance on any forward-looking statements. These forward-looking statements are based on information available to Urovant as of the date of this press release and speak only as of the date of this release. Urovant disclaims any obligation to update these forward-looking statements, except as may be required by law.

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

Source: Urovant Sciences

Urovant Sciences
Kellie Lao
Investor inquiries: Investors@Urovant.com
Media inquiries: Media@Urovant.com

Urovant Sciences Ltd. Announces Pricing of Initial Public Offering

BASEL, Switzerland and IRVINE, Calif., September 26, 2018 /PRNewswire/ Urovant Sciences Ltd. (Nasdaq: UROV), a clinical-stage biopharmaceutical company focused on developing therapies for urologic conditions, today announced the pricing of its initial public offering of 10,000,000 common shares at a price to the public of $14.00 per share, for total gross proceeds of $140,000,000, before deducting underwriting discounts and commissions and other offering expenses payable by Urovant. In addition, Urovant has granted the underwriters a 30-day option to purchase up to 1,500,000 additional common shares at the initial public offering price less the underwriting discounts and commissions. The common shares are expected to begin trading on The Nasdaq Global Select Market under the symbol “UROV” on September 27, 2018. The offering is expected to close on October 1, 2018, subject to customary closing conditions. All of the common shares are being offered by Urovant.

J.P. Morgan, Jefferies and Cowen are acting as joint book-running managers for the offering.

The offering will be made only by means of a prospectus. A copy of the final prospectus, when available, may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or email at prospectus-eq_fi@jpmchase.com; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 547-6340, or by email at Prospectus_Department@jefferies.com; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, telephone: (631) 274-2806, fax: (631) 254-7140.

A registration statement relating to these securities has been filed with, and declared effective by, the U.S. Securities and Exchange Commission. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Urovant Sciences

Urovant 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 in an international pivotal Phase 3 clinical trial for the treatment of overactive bladder. Urovant’s second product candidate, hMaxi-K, is a novel gene therapy being developed for patients with overactive bladder who have failed oral pharmacological therapy.

Contacts

Investor inquiries: Investors@Urovant.com

Media inquiries: Media@Urovant.com

Kyorin Receives Approval from Japan’s Ministry of Health, Labour and Welfare for Vibegron for Overactive Bladder

  • Kyorin secures first commercial approval for vibegron
  • Vibegron will be a new treatment option in Japan, where an estimated 10.4 million people suffer from overactive bladder symptoms defined as the sudden urge to urinate, frequent urination and urge incontinence

BASEL, Switzerland and IRVINE, Calif.Sept. 24, 2018 /PRNewswire/ — Urovant Sciences, a clinical-stage biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced that Kyorin Pharmaceutical Co., Ltd. (Kyorin) received marketing approval from Japan’s Ministry of Health, Labour and Welfare for vibegron for the treatment of adults with overactive bladder (OAB) in Japan.

Kyorin licensed vibegron for Japan from Merck & Co., Inc. in 2014, and later expanded the license to include certain other Asian countries in 2017. Urovant licensed rights to vibegron for the United States and the rest of the world from Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. in 2017 and subsequently entered into a collaboration agreement with Kyorin later that year. Under the collaboration agreement, Urovant and Kyorin share information related to the development of vibegron, including clinical trial and nonclinical study data.

Kyorin developed vibegron for Japan and submitted its marketing application to Japan’s Pharmaceuticals and Medical Devices Agency in September 2017. In Kyorin’s Phase 3 clinical trial, vibegron demonstrated a significant reduction in frequency of urination, urgency episodes, urinary urge incontinence episodes and total incontinence episodes. Vibegron also was observed to be well tolerated in Kyorin’s Phase 3 program.

“Kyorin’s approval of vibegron in Japan will address a substantial need and bring patients with OAB in Japan a new treatment option to discuss with their physician,” said Keith Katkin, President and Chief Executive Officer of Urovant. “We are making significant progress with our international Phase 3 clinical trial and look forward to reporting top-line results next year.”

Urovant initiated its international pivotal Phase 3 clinical trial of vibegron in adults with OAB earlier this year. Vibegron is investigational in the United States and has not been approved by the U.S. Food and Drug Administration.

About Overactive Bladder
Overactive bladder 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 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. Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant’s second product candidate, hMaxi-K, 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, including statements regarding Urovant’s plans to advance the clinical development of vibegron, report results of its Phase 3 clinical trial, and develop additional treatments for urologic diseases. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost, and timing of Urovant’s development activities, including the timing of the initiation and completion of clinical trials and the timing of expected regulatory filings; the clinical utility and potential attributes and benefits of vibegron, including reliance on collaboration partners and the ability to procure additional sources of financing; and our intellectual property position, including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs. Vibegron is investigational and has not been approved by the U.S. Food and Drug Administration.

These forward-looking statements are based on information available to Urovant as of the date of this press release and speak only as of the date of this release. Urovant disclaims any obligation to update these forward-looking statements, except as may be required by law.

For the estimate of individuals in Japan who suffer from symptoms of overactive bladder, see Clinical Guidelines for Overactive Bladder Syndrome 2nd Edition, Japanese Continence Society

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

Contact

Investor inquiries: Investors@Urovant.com

Urovant Sciences Licenses Novel Gene Therapy for Overactive Bladder

  • There are no currently available FDA-approved gene therapy treatments for overactive bladder
  • Urovant expects to initiate Phase 2 hMaxi-K study in 2019

BASEL, Switzerland and IRVINE, Calif., August 28, 2018/PRNewswire – Urovant Sciences, a clinical-stage biopharmaceutical company focused on developing therapies for urologic conditions, today announced it has licensed a novel investigational gene therapy for patients with overactive bladder (OAB) symptoms who have failed oral pharmacologic therapy.

Urovant has licensed global rights for the development and commercialization of hMaxi-K from Ion Channel Innovations. There are no currently available FDA-approved gene therapy treatments for overactive bladder.

hMaxi-K has been evaluated in two Phase 1 studies in OAB patients including a small, double-blind, placebo-controlled Phase 1b clinical trial as an intravesical injection in women with overactive bladder symptoms. Ion Channel Innovations completed the Phase 1b study in 2017 and found hMaxi-K to be generally well tolerated. Clinical results of the trial, which included a limited number of patients (n=13), indicated dose-dependent improvements in urinary urgency and frequency, achieving statistical significance (p<0.05) in the high dose cohort.

“We are pleased to add the gene therapy hMaxi-K to our clinical development portfolio. We are eager to study the potential of hMaxi-K as an alternative therapy for OAB patients who are not getting adequate relief from other therapies,” said Keith A. Katkin, President and Chief Executive Officer of Urovant. “Urovant also has access to gene therapy expertise through the Roivant family of companies.”

Urovant plans to meet with the FDA and initiate a Phase 2 clinical study in 2019 to investigate hMaxi-K as a novel treatment for OAB patients who have not responded to other pharmacological therapies.

Earlier this year, Urovant initiated a Phase 3 clinical trial program for vibegron, an investigational oral β3-adrenergic agonist being studied as a second-line treatment in adults with symptoms of OAB. Urovant expects to report top-line results for its Phase 3 trial of vibegron next year.

About Overactive Bladder
Overactive bladder is a clinical condition characterized by the sudden urge to urinate, with or without accidental urinary leakage, and usually with increased frequency. 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 and anxiety and have a negative impact on quality of life.2

About Urovant Sciences
Urovant is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant’s lead product candidate, vibegron, is a potent and selective β3-adrenergic agonist being developed for an oral, once-daily treatment for overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant intends to develop treatments for additional urologic diseases. For more information, please visit urovant.com.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding Urovant’s plans to advance the clinical development of hMaxi-K and vibegron. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost and timing of Urovant’s product development activities, including the timing of the initiation and completion of clinical trials and the timing of expected regulatory filings; the clinical utility and potential attributes and benefits of hMaxi-K and vibegron, including reliance on collaboration partners and the ability to procure additional sources of financing; and our intellectual property position including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs. hMaxi-K and vibegron are investigational and have not been approved by the U.S. Food and Drug Administration.

These forward-looking statements are based on information available to Urovant as of the date of this press release and speak only as of the date of this release. Urovant disclaims any obligation to update these forward-looking statements, except as may be required by law.

 

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

 

Contacts

Investor inquiries: Investors@Urovant.com

Media inquiries: Media@Urovant.com

Urovant Sciences Appoints Sef Kurstjens and Pierre Legault to its Board of Directors

BASEL, Switzerland and IRVINE, Calif., July [9], 2018 /PRNewswire/ — Urovant Sciences, a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced the appointments of Sef Kurstjens, M.D., Ph.D. and Pierre Legault to its board of directors.

“I am excited that Sef Kurstjens and Pierre Legault have agreed to join the Urovant board,” said Keith Katkin, President and Chief Executive Officer of Urovant. “Both Sef and Pierre are accomplished executives with significant experience in the biopharmaceutical industry.”

“I am also pleased by the addition of Sef and Pierre to our board,” said Mayukh Sukhatme, President of Roivant Pharma and the incoming chairman of the Urovant board of directors. “We believe there are big things ahead for Urovant and we look forward to benefiting from Sef’s and Pierre’s expertise and counsel as we grow to meet the unmet medical needs of urology patients.”

Dr. Kurstjens and Mr. Legault join Keith Katkin, Mayukh Sukhatme, M.D. and Matthew Gline on the Urovant board of directors.

Dr. Kurstjens has over 27 years of biotech and pharmaceutical drug development experience, having most recently served as Chief Medical Officer at Astellas Pharma Inc. from 2013 to 2018. Dr. Kurstjens had responsibility for Astellas’ Development, Regulatory Affairs, Medical Affairs, Pharmacovigilance and Quality Assurance divisions, and was a member of the Corporate Executive Committee. Dr. Kurstjens also served as President and Chief Executive Officer at Agensys, Inc., an affiliate of Astellas, from 2010 to 2013.

Prior to joining Astellas, Dr. Kurstjens served as Chief Medical Officer and Head of Global Drug Development at Allergan plc from 2007 to 2013, where he led all Global Drug Development, Clinical Operations, and Drug Safety for the Urology, Neurology, Ophthalmology and Dermatology global therapeutic areas. Dr. Kurstjens received his training in medicine and physiology at the University of the Witwatersrand Medical School in Johannesburg, South Africa.

“I am delighted to join the board of a company focused on meeting the needs of urology patients and I look forward to working with Keith and the rest of Urovant’s highly experienced management team,” said Dr. Kurstjens.

Mr. Legault has over 35 years of experience in the pharmaceutical and biotechnology industries. He currently serves as the Chairman of the board of directors for both Artios Pharma Limited and Poxel SA, as well as a member of the board of directors of Syndax Pharmaceuticals Inc. and Clementia Pharmaceutical Inc. Mr. Legault’s previous roles include serving as Chief Executive Officer of Prosidion Ltd., a subsidiary of Astellas, Chief Financial Officer of OSI Pharmaceuticals, Inc., and various global positions, including President, Chief Executive Officer and Chief Financial Officer at several legacy companies of the Sanofi-Aventis group. Mr. Legault has also served on the board of directors of several other healthcare companies, including Regado Biosciences, Inc. and ARMO Biosciences, Inc. He earned his B.B.A. from HEC Montreal and his M.B.A. from McGill University.

“I am very excited to join the Urovant board of directors,” said Mr. Legault. “Having devoted most of my career to the development and commercialization of therapies in multiple disease areas, I look forward to leveraging my experience to support Urovant as it develops innovative urological drugs.”

About Urovant Sciences
Urovant is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant’s product candidate, vibegron, is an oral, once-daily, small molecule that, based on in vitro data, is a potent and highly selective beta-3 agonist. Vibegron is currently being evaluated in a large, international pivotal Phase 3 clinical trial for the treatment of overactive bladder (“OAB”). Vibegron is also being evaluated for two additional potential indications, treatment of OAB in men with benign prostatic hyperplasia and the treatment of pain associated with irritable bowel syndrome.

Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding Urovant’s plans to advance the clinical development of vibegron. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost and timing of Urovant’s product development activities, including the timing of the initiation and completion of clinical trials and the timing of expected regulatory filings; the clinical utility and potential attributes and benefits of vibegron, including reliance on collaboration partners and the ability to procure additional sources of financing; and our intellectual property position including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs. Vibegron is investigational and has not been approved by the U.S. Food and Drug Administration or any comparable federal agency in any other jurisdiction.
These forward-looking statements are based on information available to Urovant as of the date of this press release and speak only as of the date of this release. Urovant disclaims any obligation to update these forward-looking statements, except as may be required by law.

Related Links
http://www.urovant.com

Urovant Sciences Strengthens Executive Management Team with Senior Hires and Establishes U.S. Headquarters in Irvine, California

  • Cornelia Haag-Molkenteller, former VP and Therapeutic Area Head, Clinical Development, for Urology, Women’s Health, and Internal Medicine at Allergan, joins as Chief Medical Officer
  • Michael McFadden, former SVP for Commercial at Avanir, joins as Chief Commercial Officer
  • Bryan Smith, former Senior Counsel at Allergan, joins as General Counsel
  • Christine Ocampo, former Chief Financial Officer at Novus Therapeutics and Chief Accounting Officer at Avanir, joins as SVP and Chief Accounting Officer
  • Nori Ebersole, former Chief Human Resources Officer at Paul Hastings and VP for Human Resources at Allergan, joins as SVP and Chief Human Resources Officer

BASEL, Switzerland and IRVINE, Calif., April 24, 2018 /PRNewswire/ — Urovant Sciences, a global biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced that it has strengthened its management team through the appointment of five senior executives: Cornelia Haag-Molkenteller M.D., Ph.D., as Chief Medical Officer, Michael McFadden as Chief Commercial Officer, Bryan E. Smith as General Counsel, Christine Ocampo as Senior Vice President and Chief Accounting Officer, and Nori Ebersole as Senior Vice President and Chief Human Resources Officer. Urovant also announced that it has established its U.S. headquarters in Irvine, California.

“Cornelia, Michael, Bryan, Christine, and Nori are all outstanding leaders in their respective fields and they will each contribute to Urovant’s success,” said Keith Katkin, Chief Executive Officer of Urovant. “As we continue to enroll patients with overactive bladder in our pivotal Phase 3 trial for vibegron, EMPOWUR, it is critical that we grow our team with the best talent in the industry to simultaneously advance our clinical programs and prepare for the eventual commercialization of our products.”

Dr. Haag-Molkenteller is a board-certified urologist with over 26 years of global experience in clinical development and medical affairs. She most recently served as Vice President and Therapeutic Area Head in Global Clinical Development for Women’s Health, Internal Medicine, Anti-Infectives, and Urology at Allergan. While at Allergan, she led multiple development projects including the clinical development of onabotulinumtoxinA for the treatment of neurogenic detrusor overactivity and overactive bladder. Before joining Allergan, Dr. Haag-Molkenteller was Vice President and Therapeutic Area Head for Clinical Development in Urology at Schwarz Biosciences (now UCB) and started her career in the pharmaceutical industry with roles in clinical development and medical affairs at Hoechst-Marion-Roussel (now Sanofi). She received her M.D. and Ph.D. from the Johann Wolfgang Goethe University in Frankfurt-am-Main, Germany and completed her clinical residency in urology in Germany.

Mr. McFadden has over 27 years of experience leading successful drug commercialization efforts across many therapeutic areas including urology. He served as Senior Vice President, Commercial at Avanir Pharmaceuticals and previously held leadership roles in commercial development, marketing, and sales at Amylin Pharmaceuticals, Pharmacia, and Eli Lilly & Company. He has participated in numerous successful pharmaceutical drug launches, including those for NUEDEXTA®, DETROL LA®, BYETTA®, ZYPREXA®, and CELEBREX®. Mr. McFadden received his B.A. in Business Administration and Accounting from Northeast Louisiana University.

Mr. Smith most recently served as Associate Vice President and Senior Counsel at Allergan, where he was chief counsel to the company’s Urology, Neurology, Aesthetics, and Dermatology business units. Mr. Smith also led Allergan’s anti-counterfeiting and anti-diversion efforts in close cooperation with the U.S. Food & Drug Administration’s Office of Criminal Investigations and other federal, state, and international law enforcement agencies. Prior to joining Allergan, Mr. Smith was a litigator at Gibson, Dunn & Crutcher LLP. Mr. Smith received his B.A. in Political Science from Brigham Young University and his J.D. from the University of Southern California Law School. After graduating from law school, Mr. Smith was a law clerk to the Honorable Cormac J. Carney in the United States District Court for the Central District of California.

Ms. Ocampo has over 20 years of accounting and finance experience, including over 15 years as the head of finance for publicly-traded companies in the healthcare industry. She most recently served as Chief Financial Officer of Novus Therapeutics. Before joining Novus, Ms. Ocampo was Chief Accounting Officer and Vice President of Finance at Avanir Pharmaceuticals from 2007 to 2015, where she played a key role in the company’s sale to Otsuka Pharmaceutical Co., Ltd. Prior to Avanir, she served as Senior Vice President, Chief Financial Officer, Chief Accounting Officer, Treasurer and Secretary of Cardiogenesis Corporation. After earning a B.A. in Business and Accounting from Seattle University, Ms. Ocampo began her career at Ernst & Young LLP. Ms. Ocampo is a licensed Certified Public Accountant.

Ms. Ebersole has over 25 years of global strategic human resources experience. She most recently served as Chief Human Resources Officer at Paul Hastings LLP, leading the redesign of its compensation system and talent acquisition. Before joining Paul Hastings, she spent 18 years at Allergan, where she was Vice President, Human Resources, partnering with executives globally on key strategic initiatives in the Urology, Neurology, Dermatology, Ophthalmology, and Aesthetics business units. At Allergan, Ms. Ebersole led numerous commercial and R&D expansions, compensation planning, leadership development, and retention strategies. She received her B.S. in Business Administration from the University of Southern California’s Marshall School of Business and currently serves on the board of Big Brothers, Big Sisters of Orange County.

About Overactive Bladder

Overactive bladder (OAB) is a condition that affects as many as 46 million adults in the United States alone. The most common symptoms of OAB include the experience of sudden urges to urinate that cannot be controlled, frequent urination, and urinary incontinence due to involuntary contractions of the detrusor muscle. While several conditions may contribute to signs and symptoms of overactive bladder, the underlying cause of OAB remains unclear.

About Vibegron

Vibegron is an investigational oral β3-adrenergic agonist being studied for the treatment of OAB. β3-adrenergic receptors play a role in the bladder fill-void cycle. By stimulating that pathway, vibegron has the potential to relax the bladder detrusor muscle. Relaxing the bladder allows it to store urine more efficiently, thereby decreasing the symptoms of OAB. Over 2,700 patients with symptoms of OAB have previously been enrolled in clinical studies evaluating the safety and efficacy of vibegron and over 2,350 individuals have received vibegron in past studies.

About Urovant Sciences

Urovant Sciences is a global biopharmaceutical company focused on developing novel therapies for urologic conditions. Urovant’s lead therapeutic candidate is vibegron, a potent and selective β3-adrenergic agonist being developed for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant intends to develop treatments for additional urologic diseases. For more information, please visit urovant.com.

Urovant Sciences Initiates Phase 3 Clinical Program for Vibegron in Patients with Overactive Bladder

  • Pivotal trial will enroll approximately 1,400 patients for 12-week treatment period
  • Program supported by prior dosing in 2,350 subjects and positive Phase 2b and Phase 3 results

BASEL, Switzerland and IRVINE, Calif., March 28, 2018 /PRNewswire/ — Urovant Sciences, a global biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced that it has initiated an international Phase 3 trial, EMPOWUR, to evaluate the safety and efficacy of vibegron, an investigational oral β3-adrenergic agonist, in adults with symptoms of overactive bladder.

“I am proud of our team’s efforts to rapidly launch this pivotal study for a promising therapy,” said Keith Katkin, Chief Executive Officer of Urovant. “Overactive bladder affects millions of individuals and patients need better alternatives to the current standard of care.”

Vibegron has been previously evaluated in 16 Phase 1 studies, one large international Phase 2b dose-ranging study in patients with overactive bladder, and a successful Phase 3 program in Japanese patients with overactive bladder.

About the Phase 3 Trial

The EMPOWUR study is a randomized, double-blind, placebo- and active comparator-controlled international Phase 3 clinical trial in men and women with symptoms of overactive bladder. The study is expected to enroll approximately 1,400 patients.

Individuals who meet eligibility requirements will be randomized to one of three groups for a 12-week treatment period: vibegron 75 mg administered orally once daily, placebo administered orally once daily, or tolterodine ER 4 mg administered orally once daily. Eligible patients completing the initial 12-week blinded assessment will be offered the opportunity to enroll in a 40-week double-blind extension study to evaluate the safety of longer-term treatment.

The co-primary efficacy endpoints of the study are:

  • Change from baseline in the average number of micturitions per 24 hours in all patients
  • Change from baseline in the average number of urge urinary incontinence (UUI) episodes per 24 hours in patients with an average of ≥ 1 UUI episodes per day prior to treatment

Secondary endpoints will include changes in the frequency of incontinence episodes and urinary urgency episodes, and self-reported quality of life scores. Adverse events will be monitored during both the trial and the extension study.

About Overactive Bladder

Overactive bladder (OAB) is a condition that affects as many as 46 million adults in the United States alone. The most common symptoms of OAB include the experience of sudden urges to urinate that cannot be controlled, frequent urination, and urinary incontinence due to involuntary contractions of the detrusor muscle. While several conditions may contribute to signs and symptoms of overactive bladder, the underlying cause of OAB remains unclear.

About Vibegron

Vibegron is an investigational oral β3-adrenergic agonist being studied for the treatment of OAB. β3-adrenergic receptors play a role in the bladder fill-void cycle. By stimulating that pathway, vibegron has the potential to relax the bladder detrusor muscle. Relaxing the bladder allows it to store urine more efficiently, thereby decreasing the symptoms of OAB. Over 2,700 patients with symptoms of OAB have previously been enrolled in clinical studies evaluating the safety and efficacy of vibegron and over 2,350 individuals have received vibegron in past studies.

About Urovant Sciences

Urovant Sciences is a global biopharmaceutical company focused on developing novel therapies for urologic conditions. Urovant’s lead therapeutic candidate is vibegron, a potent and selective β3-adrenergic agonist being developed for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Urovant has licensed global rights, excluding Japan and certain Asian territories, for the development and commercialization of vibegron. Urovant intends to develop treatments for additional urologic diseases. For more information, please visit urovant.com.

Related Links

http://www.urovant.com

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