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

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