Myovant Sciences Provides Recent Corporate Updates and Reports Financial Results for First Fiscal Quarter Ended June 30, 2019
-Positive results from both Phase 3 LIBERTY trials and bioequivalence study supports submission of NDA for uterine fibroids which is expected by year end 2019 and MAA which is expected by Q1-2020-
-Top-line data from Phase 3 HERO trial in advanced prostate cancer expected by year end 2019 with Phase 3 SPIRIT data in endometriosis expected in Q1 and Q2 2020-
“Myovant Sciences recently announced positive top-line data for the LIBERTY 1 and LIBERTY 2 studies evaluating relugolix combination therapy in women with uterine fibroids, as well as the positive results from a separate bioequivalence study supporting a potential one pill, once-a-day dosing regimen of relugolix combination therapy,” said
First Fiscal Quarter 2019 and Recent Business Highlights
Relugolix Phase 3 Clinical Programs
May 14, 2019, Myovant Sciencesannounced positive top-line results from the LIBERTY 1 Phase 3 study evaluating relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) once-a-day in women with uterine fibroids and heavy menstrual bleeding. The study met its primary endpoint with a p-value of <0.0001 and achieved six key secondary endpoints with a well-tolerated safety profile.
July 23, 2019, Myovant Sciencesannounced positive top-line results from the LIBERTY 2 Phase 3 study evaluating relugolix combination therapy in women with uterine fibroids and heavy menstrual bleeding. This study also met its primary endpoint with a p-value of <0.0001 and achieved six key secondary endpoints with a well-tolerated safety profile.
July 23, 2019, Myovant Sciencesalso announced that the single-tablet relugolix combination therapy met all required FDAcriteria in a separate bioequivalence study supporting a potential one-pill, once-a-day dosing regimen of relugolix.
- Based on the positive top-line results for LIBERTY 1 and LIBERTY 2,
Myovant Sciencescurrently plans to submit an NDA for one-pill, once-a-day relugolix combination therapy for the treatment of heavy menstrual bleeding and uterine fibroids to the FDAin the fourth quarter of calendar year 2019 and the Marketing Authorisation Application to the European Medicines Agencyin the first quarter of calendar year 2020.
- Enrollment of approximately 130 additional men with metastatic prostate cancer in the Phase 3 HERO study was completed in July 2019. The objective of enrolling these men was to assess the secondary objective of demonstrating that relugolix can delay the time to progression of the lethal state of the disease, castration-resistant prostate cancer, as compared to leuprolide.
MVT-602 Clinical Program
Myovant Sciencescompleted a successful dose-finding pharmacokinetic/pharmacodynamic Phase 2a study of MVT-602, a kisspeptin-1 receptor agonist, in healthy women undergoing a minimal controlled ovarian stimulation protocol. Top-line results were presented at the European Society of Human Reproductionin Vienna, Austriain June 2019. The study demonstrated that MVT-602 was generally well-tolerated and produced the desired luteinizing hormone surge associated with high and dose-dependent rates of ovulation in healthy women following a minimal controlled ovarian stimulation protocol.
June 4, 2019, Myovant Sciencescompleted an underwritten public equity offering, receiving net proceeds of approximately $134.5 million.
- In the first quarter of fiscal year 2019,
Myovant Sciencesreceived aggregate net proceeds of $2.5 millionpursuant to the issuance of common shares under its “at-the-market” equity offering program.
First Fiscal Quarter 2019 Financial Summary
Research and development (R&D) expenses for the quarter ended June 30, 2019, were
General and administrative (G&A) expenses for the quarter ended June 30, 2019, were
Interest expense for the quarter ended June 30, 2019, was
Interest income for the quarter ended June 30, 2019, was
Net loss for the quarter ended June 30, 2019, was
Capital resources: Cash and cash equivalents totaled
Relugolix is a once-a-day, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol and progesterone production, hormones known to stimulate uterine fibroids and endometriosis.
MVT-602 is an oligopeptide kisspeptin-1 receptor agonist. Kisspeptin, the ligand, is a naturally-occurring peptide that stimulates GnRH release and is required for puberty and maintenance of normal reproductive function, including production of sperm, follicular maturation and ovulation, and production of estrogen and progesterone in women and testosterone in men. A Phase 2a clinical study in healthy female volunteers to characterize the dose-response curve in a minimal controlled ovarian stimulation setting has been completed.
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 regarding Myovant Sciences’ intent, belief, or expectations regarding future events or results and can be identified by words such as “anticipate,” “aspire,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “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 Myovant Sciences’ aspirations to become the leading healthcare company focused on innovative treatments for women’s health and prostate cancer, Myovant Sciences’ intentions to expand its development pipeline to include other potential treatments for women’s health and prostate cancer, Myovant Sciences’ plans to submit the uterine fibroids NDA to the
Myovant Sciences’ forward-looking statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements.
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
|Three Months Ended June 30,|
|Research and development (1)||$||51,117||$||51,341|
|General and administrative (1)||14,152||8,742|
|Total operating expenses||65,269||60,083|
|Other (income) expense, net||(705||)||289|
|Loss before income taxes||(67,591||)||(61,989||)|
|Income tax expense||313||145|
|Net loss per common share — basic and diluted||$||(0.89||)||$||(0.98||)|
|Weighted average common shares outstanding — basic and diluted||76,468,347||63,310,177|
|(1) Includes the following share-based compensation expenses:|
|Research and development||$||2,548||$||1,561|
|General and administrative||$||3,904||$||2,683|
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)
|June 30, 2019||March 31, 2019|
|Cash and cash equivalents||$||226,734||$||156,074|
|Prepaid expenses and other current assets||8,693||10,194|
|Income tax receivable||331||524|
|Total current assets||235,758||166,792|
|Property and equipment, net||2,057||2,071|
|Operating lease right-of-use asset||9,181||—|
|Liabilities and Shareholders’ Equity|
|Operating lease liability||813||—|
|Due to Roivant Sciences Ltd., Roivant Sciences, Inc., and Roivant Sciences GmbH||196||121|
|Current maturities of long-term debt||10,867||6,142|
|Total current liabilities||68,896||71,973|
|Deferred interest payable||3,790||2,273|
|Long-term operating lease liability||9,550||—|
|Long-term debt, less current maturities||89,070||93,240|
|Total shareholders’ equity||79,567||4,334|
|Total liabilities and shareholders’ equity||$||250,873||$||172,977|
Chief Financial Officer
Source: Myovant Sciences, Inc.