On February 7, 2019 Myovant Sciences (NYSE: MYOV), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of women’s health and endocrine diseases, reported corporate updates and reported financial results for the third fiscal quarter ended December 31, 2018 (Press release, Myovant Sciences, FEB 7, 2019, http://investors.myovant.com/news-releases/2019/02-07-2019-210634214 [SID1234533114]).
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"As we enter this new year, we look forward to our first Phase 3 data from our LIBERTY program in uterine fibroids. The recent approval by Takeda for Relumina (relugolix 40 mg tablets) for the treatment of uterine fibroids in Japan, further validates our belief in relugolix as a critical treatment for people with uterine fibroids in the U.S. and Europe," said Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences. "We continue to be on track to deliver data from both our LIBERTY and HERO programs this year, however enrollment for our SPIRIT endometriosis studies has taken longer than anticipated. While we remain confident that enrollment will be completed in 2019, we now anticipate top-line data for SPIRIT will be available in the first quarter of next year."
Recent Business Highlights and Upcoming Milestones
Relugolix Phase 3 Clinical Programs
Completed patient enrollment in the Phase 3 LIBERTY 2 trial evaluating relugolix in combination with estradiol and a progestin in women with heavy menstrual bleeding associated with uterine fibroids.
Expect top-line data from LIBERTY 1 and LIBERTY 2 Phase 3 trials evaluating the safety and efficacy of relugolix in combination with estradiol and a progestin in women with heavy menstrual bleeding associated with uterine fibroids in Q2 and Q3 of 2019, respectively, and assuming positive data, submission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in Q4 of 2019.
Expect top-line data from the HERO Phase 3 trial evaluating the safety and efficacy of relugolix in men with advanced prostate cancer in Q4 2019, and assuming positive data, submission of the NDA to the FDA in early 2020.
Expect completion of enrollment in both SPIRIT 1 and SPIRIT 2 Phase 3 trials evaluating the safety and efficacy of relugolix in women with pain associated with endometriosis this year, with top-line data expected in Q1 2020.
On January 8, 2019, Takeda Pharmaceutical Company Limited and ASKA Pharmaceutical Co., Ltd. announced that Takeda has obtained marketing authorization in Japan from the Ministry of Health, Labour and Welfare for Relumina Tablets 40 mg (generic name: relugolix) for the improvement of symptoms of uterine fibroids (heavy menstrual bleeding, lower abdominal pain, lower back pain, and anemia).
MVT-602 Clinical Program
Completed enrollment in the dose-finding pharmacokinetic/pharmacodynamic Phase 2a study of MVT-602, a kisspeptin-1 receptor agonist, in healthy women undergoing a controlled ovarian stimulation protocol. Top-line results are expected to be reported in the first half of 2019.
Corporate
Raised proceeds of $92.0 million pursuant to our existing financing arrangement with NovaQuest in late December 2018.
Third Fiscal Quarter 2018 Financial Summary
Research and development (R&D) expenses for the quarter ended December 31, 2018, were $58.4 million compared to $34.9 million for the comparable period in 2017. The increase for the quarter primarily reflects the progress of Myovant’s ongoing Phase 3 clinical trials of relugolix, which were initiated in 2017, as well as additional personnel-related expenses and MVT-602 clinical trial expenses.
General and administrative (G&A) expenses for the quarter ended December 31, 2018, were $10.7 million compared to $6.6 million for the comparable period in 2017. The increase for the quarter primarily reflects increases in personnel-related expenses, professional service fees, and other administrative expenses to support Myovant’s headcount growth and expanding operations.
Net interest expense for the quarter ended December 31, 2018, was $1.6 million compared to $0.9 million in the comparable prior year period. Net interest expense consists of interest expense related to financing agreements with NovaQuest and Hercules Capital, Inc., as well as the associated non-cash amortization of debt discount and issuance costs, partially offset by interest income earned on cash equivalents.
Net loss for the quarter ended December 31, 2018, was $70.6 million, compared to $41.8 million for the comparable period in 2017. On a per common share basis, net loss was $1.04 and $0.70 for the quarters ended December 31, 2018, and 2017, respectively. The increases in the net loss and net loss per common share for the quarter were driven primarily by the increase in costs outlined above.
Capital resources: Cash and cash equivalents totaled $183.0 million at December 31, 2018. An additional $40.6 million of capacity remains available under the "at-the-market" equity offering program that Myovant initiated in April 2018.
About Relugolix
Relugolix is an oral, once-daily, small molecule that acts as a gonadotropin-releasing hormone, or GnRH, receptor antagonist. More than 2,150 study participants have received treatment with relugolix in Phase 1, Phase 2 and Phase 3 clinical trials. In completed trials, relugolix was generally well tolerated and suppressed estrogen and progesterone levels in women and testosterone levels in men. Common side effects observed were consistent with suppression of these hormones.
In the ongoing Phase 3 LIBERTY clinical trials in women with heavy menstrual bleeding associated with uterine fibroids and the ongoing Phase 3 SPIRIT clinical trials in women with pain associated with endometriosis, relugolix is undergoing evaluation in combination with estradiol and norethindrone acetate, a progestin, and as monotherapy. Myovant is studying whether the combination optimizes estradiol levels to the range required to treat the signs and symptoms of endometriosis and uterine fibroids while minimizing the side effects associated with low estrogen levels, which include bone mineral density loss and hot flashes. The ongoing Phase 3 HERO study is evaluating relugolix monotherapy in men with advanced prostate cancer.
About MVT-602
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 trial in healthy female volunteers to characterize the dose-response curve in the controlled ovarian stimulation setting has completed enrollment.