Myovant Sciences Provides Recent Corporate Updates and Reports Financial Results for Third Fiscal Quarter Ended December 31, 2019
- 96.7% response rate in Phase 3 HERO study support submission of New Drug Application (NDA) for relugolix monotherapy tablet for advanced prostate cancer in the second quarter of calendar year 2020
- 87.7% one-year response rate in LIBERTY open-label extension study supports submission of NDA for relugolix combination tablet for women with heavy menstrual bleeding associated with uterine fibroids in
- Enrollment completed in Phase 3 SPIRIT 2 and SPIRIT 1 studies in women with pain associated with endometriosis with top-line results expected in the first and second quarters of calendar year 2020, respectively
- Closed low-interest loan facility from
“The next six months promise to be an inflection point for Myovant as we expect to submit NDAs for prostate cancer and uterine fibroids in the U.S. and announce data from two Phase 3 studies in endometriosis,” said
Third Fiscal Quarter 2019 and Recent Business Highlights
Relugolix Phase 3 Clinical Programs
November 2019, Myovant announced that the Phase 3 HERO study evaluating the safety and efficacy of once-daily, oral relugolix monotherapy (120 mg) over 48 weeks in 934 men with advanced prostate cancer met its primary efficacy endpoint with a 96.7% response rate and all tested key secondary endpoints, while demonstrating 54% fewer major cardiovascular events as compared with leuprolide injections administered every three months. Myovant anticipates submitting its NDA for relugolix monotherapy tablet for men with advanced prostate cancer in the second quarter of calendar year 2020.
February 2020, Myovant announced positive one-year safety and efficacy data from the LIBERTY open-label extension study with an 87.7% response rate and, on average, an 89.9% reduction in menstrual blood loss from baseline, while demonstrating maintenance of bone mineral density through one year consistent with LIBERTY 1 and 2. Myovant expects to submit its NDA for relugolix combination tablet for women with heavy menstrual bleeding associated with uterine fibroids in April 2020. The NDA submission, for which Myovant no longer expects to use a priority review voucher, will include complete one-year safety and efficacy data from the LIBERTY open-label extension study, key data that may positively impact the labeled duration of use of the relugolix combination tablet. Myovant also anticipates submitting a Marketing Authorization Application (MAA) to the European Medicines Agencyin the first quarter of calendar year 2020.
- Myovant completed patient recruitment in SPIRIT 2 in
August 2019and in SPIRIT 1 in October 2019, enrolling 623 women and 638 women, respectively. The SPIRIT 1 and 2 are replicate Phase 3 studies evaluating the safety and efficacy of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with pain associated with endometriosis. Myovant expects to report top-line results from SPIRIT 2 and SPIRIT 1 in the first and second quarters of calendar year 2020, respectively.
December 2019, Myovant successfully completed one-year stability studies for the relugolix combination tablet in support of potential commercialization.
December 2019, Roivant Sciences transferred a majority of Myovant’s outstanding common shares to Sumitovant Biopharma Ltd.(Sumitovant), a subsidiary of Sumitomo Dainippon Pharma. Concurrent with the transfer of these shares, Myovant entered into a low interest (3-month LIBOR plus 3%) revolving loan facility of up to $400 millionwith Sumitomo Dainippon Pharma. In addition, Hiroshi Nomura, Representative Director, President and CEO of Sumitomo Dainippon Pharma, and Adele Gulfo, Chief Business and Commercial Development Officer at Sumitovant, joined Myovant’s Board of Directors.
December 2019, Myovant used initial proceeds of $113.7 millionfrom the Sumitomo Dainippon Pharmaloan facility to repay all of Myovant’s outstanding obligations to NovaQuest Capital Management(NovaQuest) and Hercules Capital, Inc.(Hercules).
December 2019, Myovant announced the promotion of Frank Karbeto President and Chief Financial Officer and Matthew Langto Chief Administrative and Legal Officer.
Third Fiscal Quarter 2019 Financial Summary
Research and development (R&D) expenses for the quarter ended December 31, 2019, were
General and administrative (G&A) expenses for the quarter ended December 31, 2019, were
Interest expense for the quarter ended December 31, 2019, was
Loss on extinguishment of debt for the quarter ended December 31, 2019, was
Interest income for the quarter ended December 31, 2019, was
Net loss for the quarter ended December 31, 2019, was
Capital resources: Cash, cash equivalents, and marketable securities totaled
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids and endometriosis, and testicular testosterone production, a hormone known to stimulate the growth of prostate cancer. Myovant is developing a relugolix combination tablet (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) for women with heavy menstrual bleeding associated with uterine fibroids and for women with pain associated with endometriosis. Myovant is also developing a relugolix monotherapy tablet (120 mg once daily) for men with advanced prostate cancer.
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.
About Myovant Sciences
Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer. The company’s lead product candidate is relugolix, a once-daily, oral GnRH receptor antagonist. The company has three late-stage clinical programs for relugolix in uterine fibroids, endometriosis, and prostate cancer. The company is also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, that has completed a Phase 2a study for the treatment of female infertility as part of assisted reproduction.
Sumitovant is a global biopharmaceutical company with offices in
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 and quotes regarding Myovant Sciences’ aspirations to become the leading healthcare company focused on innovative treatments for women’s health and prostate cancer, Myovant Sciences’ plans and expected timing to submit regulatory filings for relugolix combination tablet and relugolix monotherapy tablet in the U.S. and
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
|Three Months Ended December 31,||Nine Months Ended December 31,|
|Research and development (1)||$||48,927||$||58,434||$||150,847||$||163,588|
|General and administrative (1)||29,142||10,686||59,897||29,738|
|Total operating expenses||78,069||69,120||210,744||193,326|
|Loss on extinguishment of debt||4,851||—||4,851||—|
|Interest expense (related party)||16||—||16||—|
|Other (income) expense, net||(567||)||(121||)||(1,151||)||147|
|Loss before income taxes||(85,413||)||(70,633||)||(223,377||)||(198,304||)|
|Income tax expense||191||—||699||233|
|Net loss per common share — basic and diluted||$||(0.96||)||$||(1.04||)||$||(2.64||)||$||(3.01||)|
|Weighted average common shares outstanding — basic and diluted||88,893,579||67,616,419||84,750,114||65,873,779|
(1) Includes the following share-based compensation expenses:
|Research and development (2)||$||5,399||$||1,840||$||11,565||$||5,247|
|General and administrative (3)||$||14,396||$||2,954||$||22,613||$||8,516|
(2) For the three and nine months ended
(3) For the three and nine months ended
Condensed Consolidated Balance Sheet
(Unaudited, in thousands)
|December 31, 2019||March 31, 2019|
|Cash and cash equivalents||$||83,073||$||156,074|
|Prepaid expenses and other current assets||12,086||10,194|
|Income tax receivable||—||524|
|Total current assets||110,974||166,792|
|Property and equipment, net||2,406||2,071|
|Operating lease right-of-use asset||11,491||—|
|Liabilities and Shareholders’ (Deficit) Equity|
|Interest payable (related party)||16||—|
|Operating lease liability||1,449||—|
|Current maturities of long-term debt||—||6,142|
|Total current liabilities||53,296||71,973|
|Deferred interest payable||—||2,273|
|Long-term operating lease liability||11,399||—|
|Long-term debt, less current maturities||—||93,240|
|Long-term debt, less current maturities (related party)||113,700||—|
|Total shareholders’ (deficit) equity||(48,888||)||4,334|
|Total liabilities and shareholders’ (deficit) equity||$||129,507||$||172,977|
President, Chief Financial Officer
Source: Myovant Sciences, Inc.