Urovant Sciences Reports Financial Results for the Fourth Fiscal Quarter and Full Fiscal Year Ended March 31, 2019

June 13, 2019 at 4:05 PM EDT

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IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Jun. 13, 2019– Urovant Sciences (Nasdaq: UROV),a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today reported financial results for the fourth fiscal quarter and full fiscal year ended March 31, 2019.

Recent Business Highlights

  • Announced positive top-line data results from the pivotal Phase 3 EMPOWUR study of vibegron in patients with overactive bladder
  • Presented EMPOWUR study results at the American Urological Association annual meeting in May
  • Initiated enrollment into the pivotal Phase 3 study of vibegron in men with OAB and benign prostatic hyperplasia (BPH), for which there is currently no approved treatment
  • Gained general alignment with U.S. Food and Drug Administration (FDA) on proposed Phase 2a protocol for URO-902, our novel gene therapy product for OAB
  • Entered into a debt financing agreement with Hercules Capital for up to $100 million

“Urovant Sciences achieved key milestones for several clinical programs for vibegron, an investigational beta-3 adrenergic agonist, driving us closer toward the goal of developing a leading specialty urology company,” said Keith A. Katkin, chief executive officer of Urovant. “We were pleased to announce positive topline data from EMPOWUR, our robust Phase 3 trial of vibegron as a treatment for adults with symptoms of overactive bladder, which demonstrated significant clinical efficacy on both co-primary endpoints, as well as all seven key secondary endpoints.”

Mr. Katkin continued, “We achieved another important clinical milestone with enrollment into the pivotal Phase 3 study of vibegron in men with OAB and BPH, an important supplemental program for vibegron as there is currently no approved treatment for concomitant OAB and BPH. Furthermore, we gained general alignment with the FDA on the proposed Phase 2a protocol for URO-902, our novel gene therapy product for OAB.”

Fiscal 2018 Financial Summary

For the year ended March 31, 2019, research and development expenses were $92.2 million and general and administrative expenses were $18.6 million compared to research and development expenses of $32.4 million and general and administrative expenses of $4.6 million in the prior fiscal year. Cash used in operations increased by $75.0 million to $109.0 million for the year ended March 31, 2019 as compared to the prior fiscal year. Net loss for the year ended March 31, 2019 was $111.3 million, or $4.43 per share. As of March 31, 2019, total cash and cash equivalents balance was $85.4 million and the financing commitment available to be drawn down by the Company from Hercules Capital as of March 31, 2019 was $30.0 million.

Fourth Fiscal Quarter 2018 Financial Summary

For the quarter ended March 31, 2019, research and development expenses were $22.9 million and general and administrative expenses were $5.9 million compared to research and development expenses of $16.4 million and general and administrative expenses of $2.7 million in the prior quarter. Cash used in operations decreased by $16.7 million to $24.0 million for the quarter ended March 31, 2019 as compared to the prior quarter. Net loss for the quarter ended March 31, 2019 was $29.0 million, or $0.96 per share.

Note to Investors

As previously announced, Urovant will hold a conference call to discuss 2018 fourth fiscal quarter and full fiscal year ended March 31, 2019 financial results today, June 13, 2019, 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 conference ID 1883414. 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 1883414. 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 recently reported positive Phase 3 trial results for its lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist being evaluated for overactive bladder (OAB). The international, pivotal trial achieved co-primary endpoints and all seven key secondary endpoints. In addition, vibegron is being evaluated in a Phase 3 study for the treatment of OAB in men with benign prostatic hyperplasia and in a Phase 2a study for abdominal pain associated with irritable bowel syndrome. 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 Sciences, a subsidiary of Roivant Sciences, Ltd., intends to develop novel treatments for additional urologic diseases. Learn more about us at 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 Company’s expectations regarding its Phase 3 study of vibegron in men with OAB and BPH; and the Company’s expectations regarding its proposed Phase 2a protocol for URO-902.

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 URO-902 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 URO-902 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 Quarterly Report on Form 10-Q for the quarter ended December 31, 2018 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.

UROVANT SCIENCES LTD.
Condensed Consolidated Statements of Operations

(unaudited; in thousands, except share and per share data)
 
  Three Months Ended March 31, Year Ended March 31,
  2019 2018 2019 2018
Operating Expenses
  Research and development(1) $ 22,890 $ 16,430 $ 92,198 $ 32,359
  General and administravtive(2)   5,935   2,698   18,585   4,640
    Total operating expenses   28,285   19,128   110,783   36,999
Other income (expense):  
  Interest expense, net   (259)     (259)  
  Other income (expense)   42   44   (257)   (38)
Loss before provision for income taxes   (29,042)   (19,084)   (111,299)   (37,037)
Provision for (benefit from) income taxes   (74)   11   47   37
Net loss $ (28,968) $ (19,095) $ (111,346) $ (37,074)
Net loss per common share–basic and diluted $ (0.96) $ (0.95) $ (4.43) $ (2.16)
Weighted average common shares outstanding&endash;basic and diluted   30,322,911   20,025,098   25,145,211   17,124,659
 
(1) Includes $409 and $367 of share-based compensation during the three months ended March 31, 2019 and 2018, respectively, and $1,296 and $2,477 of share-based compensation during the year ended March 31, 2019 and 2018.
(2) Includes $941 and $370 of share-based compensation during the three months ended March 31, 2019 and 2018, respectively, and $2,682 and $694 of share-based compensation during the year ended March 31, 2019 and 2018.
UROVANT SCIENCES LTD.
Condensed Consolidated Balance Sheets

(unaudited; in thousands)
 
  March 31, 2019 March 31, 2018
Assets
Current Assets:
  Cash and cash equivalents $ 85,353 $ 7,194
  Restricted cash   243  
  Prepaid expenses and other current assets   12,914   5,196
    Total current assets   98,510   12,390
  Furniture and equipment, net   923   510
  Restricted cash, net of current portion   600  
  Other assets   88   84
Total assets $ 100,121 $ 12,984
 
Liabilities and Shareholders’ Equity
Current liabilities:
  Accounts payable $ 1,925 $ 833
  Accrued expenses   9,877   3,595
  Due to Roivant Sciences Ltd.   15   1,482
    Total current liabilities   11,817   5,910
Long-term debt   13,534  
    Total liabilities   25,351   5,910
Total shareholders’ equity   74,770   7,074
Total liabilities and shareholders’ equity $ 100,121 $ 12,984

View source version on businesswire.com: https://www.businesswire.com/news/home/20190613005014/en/

Source: Urovant Sciences

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

Urovant Sciences Reports 2019 First Fiscal Quarter Financial Results

August 13, 2019 at 4:05 PM EDT

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IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Aug. 13, 2019– Urovant Sciences (Nasdaq: UROV),a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today reported financial results for the 2019 first fiscal quarter ended June 30, 2019.

Recent Business Highlights

  • Announced the ambulatory blood pressure study for vibegron achieved its primary endpoint demonstrating that vibegron does not have an effect on daytime systolic ambulatory blood pressure compared to placebo (where no effect was defined as a change from baseline of less than 3.5 mm Hg compared to placebo within a 90% confidence interval).
  • Presented positive topline results from the Phase 3 EMPOWUR study of 75 mg vibegron for overactive bladder at the annual AUA meeting in May.
  • Completed a productive pre-NDA meeting with the FDA in preparation for our anticipated New Drug Application (NDA) filing by early 2020.
  • Completed enrollment in Part 1 of the two-part OAB/BPH study in men.
  • Finalized Phase 2a protocol for URO-902, our novel gene therapy product for OAB and expect to start patient enrollment by the end of fourth quarter 2019.

“During the last quarter, Urovant Sciences continued to make excellent progress towards its vision of becoming a leading specialty urology company,” said Keith A. Katkin, chief executive officer of Urovant. “Today, we are very pleased to announce the successful completion of the vibegron ambulatory blood pressure study. This study will be an important component of our NDA and further supports the favorable safety profile of vibegron. We also remain on schedule to report results for the long-term extension portion of the phase 3 EMPOWUR study by the end of this quarter and are well underway in preparing to file the vibegron NDA by early 2020.”

First Fiscal Quarter 2019 Financial Summary

For the quarter ended June 30, 2019, research and development expenses were $22.0 million and general and administrative expenses were $5.5 million. Net loss for the quarter ended June 30, 2019 was $28.5 million, or $0.94 per share, and cash used in operations was $22.5 million. As of June 30, 2019, total cash and cash equivalents was $62.4 million or $92.4 million with the $30 million available to be drawn down from Hercules Capital by September 30, 2019.

Note to Investors

As previously announced, Urovant will hold a conference call to discuss 2019 first fiscal quarter ended June 30, 2019 financial results today, August 13, 2019, 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 conference ID 7747888. 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 7747888. 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 recently reported positive Phase 3 trial results for its lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist being evaluated for overactive bladder (OAB). The international, pivotal trial achieved both co-primary endpoints and all seven key secondary endpoints. In addition, vibegron is being evaluated in a Phase 3 study for the treatment of OAB in men with benign prostatic hyperplasia and in a Phase 2a study for abdominal pain associated with irritable bowel syndrome. 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 Sciences, a subsidiary of Roivant Sciences, Ltd., intends to develop novel treatments for additional urologic diseases. Learn more about us at 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 Company’s expectations regarding its anticipated NDA filing for vibegron for OAB; the Company’s expectations regarding its Phase 3 study of vibegron in men with OAB and BPH; and the Company’s expectations regarding its Phase 2a study for URO-902.

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 URO-902 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 URO-902 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 most recently filed Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q filed with the SEC, as such risk factors may be amended, supplemented or superseded from time to time by other filings 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 Balance Sheets

(unaudited; in thousands)
 
  Three Months Ended June 30,
  2019 2018
Operating expenses:  
  Cash and cash equivalents1 $ 22,014 $ 27,965
  General and administrative2   5,465   3,504
    Total operating expenses   27,479   31,469
Other income (expense):  
  Interest expense, net   (513)  
  Loss on disposal of furniture and equipment   (236)  
  Other income (expense)   (190)   229
Loss before provision for income taxes   (28,418)   (31,240)
Provision for income taxes   67   55
Net loss $ (28,485) $ (31,295)
Net loss per common share—basic and diluted $ (0.94) $ (1.56)
Weighted average common shares outstanding—basic and diluted   30,325,169   20,025,098
 
(1) Includes $265 and $452 of share-based compensation expense during the three months ended June 30, 2019 and 2018, respectively.
(2) Includes $782 and $354 of share-based compensation expense during the three months ended June 30, 2019 and 2018, respectively.
Condensed Consolidated Balance Sheets
(unaudited; in thousands)
 
  June 30, 2019 March 31, 2019
Assets:  
  Current Assets:  
  Cash and cash equivalents $ 62,360 $ 85,353
  Restricted cash   243   243
  Prepaid expenses and other current assets   8,416   12,914
    Total current assets   71,019   98,510
  Furniture and equipment, net   1,203   923
  Operating lease right-of-use assets   3,386  
  Restricted cash, net of current portion   623   600
  Other assets   21   88
Total assets $ 76,252 $ 100,121
 
Liabilities and Shareholders’ Equity  
Current liabilities:  
  Accounts payable $ 2,971 $ 1,925
  Accrued expenses   8,287   9,877
  Due to Roivant Sciences Ltd.   97   15
  Current portion of operating lease liabilities   92  
    Total current liabilities   11,447   11,817
Long-term debt   13,728   13,534
Operating lease liabilities, net of current portion   3,357  
  Total liabilities   28,532   25,351
Total shareholders’ equity   47,720   74,770
Total liabilities and shareholders’ equity $ 76,252 $ 100,121

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Source: Urovant Sciences

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

Urovant Sciences Reports Positive Long-Term Data from the Double-Blind Extension of the Phase 3 EMPOWUR Study of Vibegron in Patients with Overactive Bladder

September 24, 2019 at 9:00 AM EDT

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  •  Vibegron further improved treatment benefit on key overactive bladder (OAB) symptoms over the 40-week extension period 
  •  41% of patients on vibegron became “dry,” defined as having no urge urinary incontinence episodes at week 52 
  •  Vibegron demonstrated a favorable long-term safety and tolerability profile consistent with previous clinical experience 
  •  Over 2,600 OAB patients have been treated with vibegron in clinical trials  
  •  New Drug Application for vibegron expected to be submitted by early 2020 

 IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Sep. 24, 2019–

 Urovant Sciences (Nasdaq: UROV), a clinical-stage biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced positive data from the ongoing double-blind extension of the Phase 3 trial of its investigational drug candidate vibegron, a next-generation, once-daily oral beta-three adrenergic agonist in development for the treatment of overactive bladder.

As previously reported, once-daily vibegron met both co-primary endpoints in the 12-week Phase 3 EMPOWUR study, achieving statistical significance over placebo on both reduction in daily urge urinary incontinence (UUI) episodes (p<0.0001) and reduction in daily micturitions (p<0.001).

Highlights from the double-blind extension of the Phase 3 EMPOWUR study include:

  • Vibegron further improved treatment benefit on key OAB symptoms (micturitions, UUI, urgency, and total incontinence) over the 40-week extension period
  • 61% of patients on vibegron achieved at least a 75% reduction in their daily urge urinary incontinence episodes from baseline at week 52
  • 41% of patients on vibegron became “dry,” defined as having no urge urinary incontinence episodes at week 52
  • Vibegron demonstrated a favorable long-term safety and tolerability profile consistent with previous clinical experience

“The double-blind extension of the EMPOWUR study provides further compelling data that vibegron has the potential to provide long-term benefits for people suffering with overactive bladder,” said Dr. Cornelia Haag-Molkenteller, Chief Medical Officer at Urovant. “These data increase our confidence in the vibegron OAB development program and we believe vibegron has the potential, if approved by the FDA, to become an exciting next-generation treatment option for patients suffering from OAB.”

More details from the extension study will be presented at future medical meetings. Urovant intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) by early 2020.

 About EMPOWUR 

EMPOWUR was 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, 506 patients who completed the EMPOWUR trial were enrolled in a 40-week double-blind extension study to evaluate the safety of longer-term treatment up to 52 weeks. The co-primary endpoints of the EMPOWUR study were: 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 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, 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 Urovant’s plans to advance the clinical development of vibegron in patients with OAB. 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; our intellectual property position, including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs; 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 most recently filed Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q filed with the SEC, as such risk factors may be amended, supplemented or superseded from time to time by other filings with the SEC. 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.

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Source: Urovant Sciences

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

Urovant Sciences Parent Company, Roivant Sciences, and Sumitomo Dainippon Pharma Enter into a Memorandum of Understanding to Create Broad Strategic Alliance

September 6, 2019 at 9:00 AM EDT

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  • Sumitomo Dainippon Pharma is expected to fully assume Roivant’s ownership interest of Urovant Sciences (approximately 75% of outstanding Urovant shares); definitive agreement expected by the end of October 2019
  • Sumitomo Dainippon Pharma is a top-ten Japanese listed multi-national pharmaceutical company with an extensive history of innovation in drug development and commercialization. Sumitomo Dainippon Pharma has over 6,000 employees and generated over $4 billion in revenue last year through commercialization of several large market pharmaceutical drugs in the U.S., including the blockbuster drug LATUDA®
  • Upon close, this transaction will provide Urovant Sciences with a global platform, enhanced commercialization resources and infrastructure, including, but not limited to, managed care, drug distribution, and manufacturing

IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Sep. 6, 2019– Urovant Sciences (Nasdaq: UROV) today announced that its parent company, Roivant Sciences, and Sumitomo Dainippon Pharma Co., Ltd. (TSE: 4506), a leading global Japanese pharmaceutical company, have entered into a non-binding memorandum of understanding for the creation of a significant multi-national Sumitomo Dainippon-Roivant Alliance (“Alliance”) that will include Roivant’s ownership interests in Urovant Sciences and four additional biopharmaceutical “Vant” companies. Roivant will collaborate with Sumitomo Dainippon Pharma, with continued involvement of Roivant’s senior leaders, to ensure the success of the Alliance and the continued support of Urovant Sciences in its mission to develop and commercialize innovative therapies for urologic conditions. Roivant and Sumitomo Dainippon Pharma expect to sign the definitive agreement for their Strategic Alliance by the end of October 2019. The transaction will be subject to customary closing conditions and any required governmental approvals.

Sumitomo Dainippon Pharma plans to support the commercialization of vibegron by leveraging the potential benefits of scale of Sumitomo Dainippon Pharma’s global commercial infrastructure including but not limited to, market access, drug distribution and manufacturing.

“We look forward to this promising new Alliance which provides significant advantages for us as we prepare for the commercial launch of vibegron,” said Keith Katkin, CEO of Urovant. “Our planned NDA filing and launch preparation for vibegron are well underway and will benefit from the partnership of a large, successful multi-national company. In addition, we are excited to have the strategic infrastructure support and proven commercial resources of Sumitomo Dainippon. This relationship should greatly enhance Urovant Sciences’ commercial approach to the US market, strengthens supply chain capabilities and should allow Urovant to fully optimize its launch plan for vibegron.”

Earlier this year, Urovant Sciences announced positive top-line data from the pivotal Phase 3 EMPOWUR trial evaluating vibegron in adults with symptoms of overactive bladder (OAB). Urovant Sciences is planning to submit a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) by early 2020. Urovant Sciences has also completed enrollment in Part 1 of its two-part Phase 3 study evaluating vibegron for symptoms of overactive bladder (OAB) in men who are receiving pharmacological treatment for benign prostatic hyperplasia (BPH). In addition, Urovant Sciences is enrolling a Phase 2 study evaluating the treatment of vibegron in patients with abdominal pain related to IBS and also expects to start patient enrollment in a Phase 2a trial evaluating novel gene therapy product URO-902 in patients with OAB by the end of the fourth quarter of 2019.

About Urovant Sciences

Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant recently reported positive Phase 3 trial results for its lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist being evaluated for overactive bladder (OAB). The international, pivotal trial achieved both co-primary endpoints and all seven key secondary endpoints. In addition, vibegron is being evaluated in a Phase 3 study for the treatment of OAB in men with benign prostatic hyperplasia and in a Phase 2a study for abdominal pain associated with irritable bowel syndrome. 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 Sciences, a subsidiary of Roivant Sciences, Ltd., intends to develop novel treatments for additional urologic diseases. Learn more about us at www.urovant.com.

About Roivant Sciences

Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. Roivant does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization. Roivant today is comprised of a central technology-enabled platform and 20 Vants with over 45 investigational medicines in clinical and preclinical development and multiple healthcare technologies. For more information, please visit www.roivant.com.

About Sumitomo Dainippon Pharma Co., Ltd.

Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China and the European Union. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 6,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.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 Roivant Sciences and Sumitomo Dainippon Pharma’s plans with respect to the Alliance, including the timing of entry into the definitive agreement, timing of closing of the Alliance and post-closing management of Urovant; the Company’s plans and strategies for the development and commercialization of innovative therapies for the treatment of urological conditions; the Company’s expectations regarding its anticipated NDA filing for vibegron for OAB; the Company’s expectations regarding its study of vibegron in men with OAB and BPH and its study of vibegron in patients with abdominal pain related to IBS; and the Company’s expectations regarding its Phase 2a study for URO-902.

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 possibility that Roivant and Sumitomo Dainippon Pharma may not enter into a definitive agreement on the terms or timing described in this press release or at all; the possibility that Roivant and Sumitomo Dainippon Pharma may be unable to obtain required governmental approvals or that other conditions to closing the transaction may not be satisfied, such that the transaction will not close or that the closing may be delayed; the potential impact to the Company if the Alliance is deemed to constitute a change in control of the Company, including under its debt and other material agreements and with respect to its tax attributes; 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 URO-902 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 URO-902 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 most recently filed Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q filed with the SEC, as such risk factors may be amended, supplemented or superseded from time to time by other filings 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.

The Memorandum is not legally binding with the exception of some stipulations. The two companies will continue to conduct necessary due diligence and engage in mutual consultations as required as they work toward the conclusion of a legally binding definitive agreement concerning detailed conditions, etc. of the Strategic Alliance by the end of October 2019.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190906005086/en/

Source: Urovant Sciences

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

Urovant Sciences to Report 2019 First Fiscal Quarter Financial Results

August 6, 2019 at 8:00 AM EDT

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IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Aug. 6, 2019– Urovant Sciences (Nasdaq: UROV),a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced it will report 2019 first fiscal quarter financial results after the close of U.S. financial markets on Tuesday, August 13, 2019.

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

The conference call numbers are (866) 470-1049 for domestic callers and (409) 217-8245 for international callers. The conference ID is 7747888.

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 7747888. 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 recently reported positive Phase 3 trial results for its lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist being evaluated for overactive bladder (OAB). The international, pivotal trial achieved both co-primary endpoints and all seven key secondary endpoints. In addition, vibegron is being evaluated in a phase 3 study for the treatment of OAB in men with benign prostatic hyperplasia and in a phase 2a study for abdominal pain associated with irritable bowel syndrome. 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 Sciences, a subsidiary of Roivant Sciences, Ltd., intends to develop novel treatments for additional urologic diseases. Learn more about us at www.urovant.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190806005207/en/

Source: Urovant Sciences

Investor inquiries: Investors@Urovant.com

Urovant Sciences to Report Financial Results for the Fourth Fiscal Quarter and Full Fiscal Year Ended March 31, 2019

June 6, 2019 at 8:00 AM EDT

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IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Jun. 6, 2019– Urovant Sciences (Nasdaq: UROV),a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced it will report financial results for the fourth fiscal quarter and full fiscal year ended March 31, 2019 after the close of U.S. financial markets on Thursday, June 13, 2019.

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

The conference call numbers are (866) 470-1049 for domestic callers and (409) 217-8245 for international callers. The conference ID is 1883414.

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 1883414. 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 recently reported positive Phase 3 trial results for its lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist being evaluated for overactive bladder (OAB). The international, pivotal trial achieved co-primary endpoints and all seven key secondary endpoints. In addition, vibegron is being evaluated in a phase 3 study for the treatment of OAB in men with benign prostatic hyperplasia and in a phase 2a study for abdominal pain associated with irritable bowel syndrome. 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 Sciences, a subsidiary of Roivant Sciences, Ltd., intends to develop novel treatments for additional urologic diseases. Learn more about us at www.urovant.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190606005124/en/

Source: Urovant Sciences

Investor inquiries: Investors@Urovant.com

Urovant Sciences to Present at Annual Roivant Pipeline Day

June 3, 2019 at 8:00 AM EDT

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IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Jun. 3, 2019– Urovant Sciences (Nasdaq: UROV),a clinical-stage biopharmaceutical company developing and commercializing innovative therapies for urologic conditions, today announced Chief Executive Officer Keith A. Katkin will present at the annual Roivant Pipeline Day on June 6, 2019 at 1:50 p.m. ET.

A live webcast for this event will be available on the Investor Relations section of the Urovant website at http://ir.urovant.com. A replay will be available for approximately 3 months.

About Roivant Pipeline Day

Roivant Pipeline Day will be held on Thursday, June 6, 2019 in New York City. The event will feature presentations and Q&A sessions from executives across the Roivant family of companies highlighting new clinical data and investments in technology. The event is scheduled to begin at 1:00 p.m. ET and will continue until approximately 4:30 p.m. ET. A live webcast will be available to interested parties. To request access to the webcast or to learn more about the event, please email pipelineday@roivant.com.

About Urovant Sciences

Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant recently reported positive Phase 3 trial results for its lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist being evaluated for overactive bladder (OAB). The international, pivotal trial achieved co-primary endpoints and all seven key secondary endpoints. In addition, vibegron is being evaluated in a phase 3 study for the treatment of OAB in men with benign prostatic hyperplasia and in a phase 2a study for abdominal pain associated with irritable bowel syndrome. 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 Sciences, a subsidiary of Roivant Sciences, Ltd., intends to develop treatments for additional urologic diseases. Learn more about us at www.urovant.com.

About Roivant Sciences

Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. Roivant does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization. For more information, please visit www.roivant.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20190603005134/en/

Source: Urovant Sciences

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

Urovant Sciences to Present at the Jefferies 2019 Healthcare Conference

May 30, 2019 at 8:00 AM EDT

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IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–May 30, 2019– Urovant Sciences (Nasdaq: UROV),a clinical-stage biopharmaceutical company focused on developing novel therapies for urologic conditions, today announced Chief Executive Officer Keith A. Katkin is scheduled to present a corporate overview at the Jefferies 2019 Healthcare Conference on Tuesday, June 4, 2019at 11:30 a.m. ET.

A live, audio webcast for this event will be available on the Investor Relations section of the Urovant website at http://ir.urovant.com for approximately three months.

About Urovant Sciences

Urovant Sciences is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant recently reported positive Phase 3 trial results for its lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist being evaluated for overactive bladder (OAB). The international, pivotal trial achieved co-primary endpoints and all seven key secondary endpoints. In addition, vibegron is being evaluated in a phase 3 study for the treatment of OAB in men with benign prostatic hyperplasia and in a phase 2a study for abdominal pain associated with irritable bowel syndrome. 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 Sciences, a subsidiary of Roivant Sciences, Ltd., intends to develop treatments for additional urologic diseases. Learn more about us at www.urovant.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190530005190/en/

Source: Urovant Sciences

Investor inquiries:
Investors@Urovant.com

Urovant Sciences to Announce Topline Results from the EMPOWUR Phase 3 Study of Vibegron in Patients with Overactive Bladder

March 18, 2019 at 4:05 PM EDT

IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Mar. 18, 2019–
Urovant Sciences (Nasdaq: UROV),a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced it will host a conference call and live webcast to discuss topline results from the EMPOWUR international pivotal phase 3 study on Tuesday, March 19, 2019 at 8:30 a.m. ET. A question and answer session will follow management’s remarks.

The conference call numbers are (866) 470-1049 for domestic callers and+1 (409) 217-8245 for international callers. The conference ID is 9455883. The webcast link to view the presentation is available at: https://edge.media-server.com/m6/p/oey7muvz.

A replay of the call will be available approximately four hours after the call and accessible for 30 days at (855) 859-2056 for domestic callers and +1 (404)-537-3406 for international callers. The conference ID is 9455883. 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 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 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 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; and 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. Secondary endpoints included changes in the frequency of urinary urgency episodes and incontinence episodes, and self-reported quality of life scores.

About Urovant Sciences

Urovant Sciences, a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, is a subsidiary of Roivant Sciences. Urovant leverages the. Roivant platform to develop therapies that address high unmet medical needs while driving greater efficiency in research, clinical development, and commercialization. Urovant’s lead product candidate, vibegron, is an oral, once-daily, small molecule beta-3 adrenergic 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.

About Roivant Sciences

Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. Roivant does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization. For more information, please visit www.roivant.com.

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

Source: Urovant Sciences

Investor inquiries: Investors@Urovant.com

Urovant Sciences Announces Positive Topline Results from Pivotal Phase 3 EMPOWUR Study of Vibegron in Patients with Overactive Bladder

OWUR Study of Vibegron in Patients with Overactive Bladder
March 19, 2019 at 8:00 AM EDT

  • Vibegron met both co-primary endpoints demonstrating highly significant reduction in daily urge urinary incontinence episodes and micturitions, compared to placebo (p<0.0001 and p<0.001, respectively)
  • Vibegron met all seven key secondary endpoints, including a clinically meaningful reduction in daily urgency episodes versus placebo (p=0.002)
  • Vibegron achieved rapid onset at two weeks in both co-primary endpoints and daily urgency episodes (p<0.001 for these endpoints) and statistically significant efficacy was maintained at all timepoints measured through the end of the study
  • Vibegron could potentially be the first new prescription drug in nearly a decade for the millions of patients suffering from overactive bladder (OAB)
  • Urovant to host investor conference call March 19, 2019

IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Mar. 19, 2019– Urovant Sciences (Nasdaq: UROV),a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced positive topline results from EMPOWUR, an international double-blind, placebo-controlled, multicenter Phase 3 clinical trial evaluating the efficacy and safety of vibegron 75mg in adults with symptoms of overactive bladder. Vibegron is an investigational once-daily oral beta-three adrenergic agonist.

In the primary efficacy analysis, once-daily vibegron met the co-primary endpoints at week 12, achieving statistical significance over placebo on both reduction in daily urge urinary incontinence (UUI) episodes (p<0.0001) and reduction in daily micturitions (p<0.001). The difference from placebo was statistically significant as early as week 2, which was the first timepoint measured, for both UUI episodes and micturitions (p<0.0001 and p<0.001, respectively), and statistically significant efficacy was maintained at all timepoints measured through the end of the study for both endpoints. Additionally, at all measured timepoints, vibegron achieved numerically better efficacy than tolterodine, the active control in this study, which is a currently available OAB treatment.

All seven pre-specified key secondary endpoints were met, including a statistically significant reduction in daily urgency episodes compared to placebo (p=0.002). Other endpoints that were not part of the topline data analysis will be presented at future medical meetings.

Vibegron was well tolerated and the most common adverse events reported versus placebo (>2% in vibegron and greater than placebo) were headache (4.0% vs 2.4%), nasopharyngitis (2.8% vs 1.7%), diarrhea (2.2% vs 1.1%), and nausea (2.2% vs 1.1%). The frequency of serious adverse events was similar across treatment arms (1.1% in placebo, 1.5% in vibegron, and 2.3% in tolterodine). The incidence of the reported adverse event of hypertension was and 2.6% in tolterodine). Full vital sign data, including blood pressure, were not part of the topline data analysis.

Based on these topline results, Urovant intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) by early 2020. EMPOWUR results will be presented at the American Urological Association Annual Meeting in Chicago in May of this year.

“There is a significant need for innovative new treatment options for OAB patients, as many patients are unable to find relief with currently available medicines,” said Dr. David R. Staskin, a key investigator in the EMPOWUR study, a leading urologist with St. Elizabeth’s Medical Center, and an Associate Professor of Urology at Tufts University School of Medicine in Boston. “The strong efficacy and safety topline results from the EMPOWUR study suggest that vibegron, if approved by the FDA, could provide an exciting next-generation treatment option for patients suffering from OAB.”

“We believe these efficacy and safety results represent a significant advancement in the treatment of OAB, positioning vibegron as a potential best in class therapy,” said Keith A. Katkin, Chief Executive Officer of Urovant. “Vibegron, if approved, could potentially be the first new prescription drug in nearly a decade for the millions of women and men suffering from OAB.”

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 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. incontinence episodes, and self-reported quality of life scores.

Conference Call

Urovant will host a conference call today March 19, 2019 at 8:30 a.m. ET to discuss topline results from EMPOWUR, the international Phase 3 pivotal trial for vibegron. The conference call numbers are (866) 470-1049 for domestic callers and +1 (409) 217-8245 for international callers. The conference ID is 9455883. The webcast link to view the presentation is available at: https://edge.media-server.com/m6/p/oey7muvz.

A replay of the call will be available approximately four hours after the call and accessible for 30 days at (855) 859-2056 for domestic callers and +1 (404)-537-3406. The conference ID is 9455883. A webcast will be website immediately after the call and available for at least 30 days.

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 negativeimpact on quality of life.2

About Urovant Sciences

Urovant Sciences, a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, is a subsidiary of Roivant Sciences. Urovant leverages the Roivant platform to develop therapies that address high unmet medical needs while driving greater efficiency in research, clinical development, and commercialization. Urovant’s lead product candidate, vibegron, is an oral, once-daily, small molecule beta-3 adrenergic 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.

About Roivant Sciences

Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. Roivant does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization. For more information, please visit www.roivant.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,” “suggest,” “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 Company’s plans to file for approval of vibegron with the FDA, and the timing of such filing and the likelihood of FDA approval.

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

Source: Urovant Sciences

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

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