On August 6, 2019 Myovant Sciences (NYSE: MYOV), a clinical-stage healthcare company focused on developing and commercializing innovative therapies for women’s health and prostate cancer, reported recent corporate updates and reported financial results for the first fiscal quarter ended June 30, 2019 (Press release, Myovant Sciences, AUG 6, 2019, View Source [SID1234538252]).

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"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 Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences. "These results confirm the potential of relugolix to offer a constellation of attributes in a single pill, taken once-a-day and we are now focused on preparing for the New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), which we plan to file by the end of this calendar year. We also look forward to reporting data from our Phase 3 prostate cancer study later this calendar year and results from our two Phase 3 endometriosis studies in the first and second quarters of calendar year 2020."
First Fiscal Quarter 2019 and Recent Business Highlights
Relugolix Phase 3 Clinical Programs

On May 14, 2019, Myovant Sciences announced 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.

On July 23, 2019, Myovant Sciences announced 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.

On July 23, 2019, Myovant Sciences also announced that the single-tablet relugolix combination therapy met all required FDA criteria 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 Sciences currently 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 FDA in the fourth quarter of calendar year 2019 and the Marketing Authorisation Application to the European Medicines Agency in 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 Sciences completed 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 Reproduction in Vienna, Austria in 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.
Corporate

On June 4, 2019, Myovant Sciences completed an underwritten public equity offering, receiving net proceeds of approximately $134.5 million.

In the first quarter of fiscal year 2019, Myovant Sciences received aggregate net proceeds of $2.5 million pursuant 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 $51.1 million compared to $51.3 million for the comparable prior year period. The composition of R&D expenses in both periods is similar, and primarily includes expenses related to Myovant Sciences’ Phase 3 clinical studies as well as personnel-related expenses for employees engaged in R&D activities. R&D expenses for the quarter ended June 30, 2018 reflected a ramp up in relugolix Phase 3 study costs primarily related to study enrollment, whereas R&D expenses for the quarter ended June 30, 2019 reflect lower relugolix Phase 3 study costs as certain studies are in the process of winding down. The decrease in relugolix Phase 3 study costs were partially offset by increases in other R&D spending related to Myovant Sciences’ preparations to seek regulatory approval for its product candidates.
General and administrative (G&A) expenses for the quarter ended June 30, 2019, were $14.2 million compared to $8.7 million for the comparable prior year period. The increase primarily reflects increases in personnel-related expenses, professional service fees, share-based compensation, and other general overhead and administrative expenses to support Myovant Sciences’ headcount growth and expanding operations.
Interest expense for the quarter ended June 30, 2019, was $3.8 million compared to $1.6 million in the comparable prior year period. The increase for the quarter was primarily the result of higher outstanding debt balances under the financing agreements as compared to the prior year period.
Interest income for the quarter ended June 30, 2019, was $0.8 million. There was no interest income for the quarter ended June 30, 2018. During the quarter ended June 30, 2019, a portion of Myovant Sciences’ cash was invested in a combination of money market funds and commercial paper. There were no such investments during the prior year period.

Net loss for the quarter ended June 30, 2019, was $67.9 million, compared to $62.1 million for the comparable prior year period. On a per common share basis, net loss was $0.89 and $0.98 for the quarters ended June 30, 2019, and 2018, respectively. The increase in the net loss for the quarter was driven primarily by the increase in costs outlined above.
Capital resources: Cash and cash equivalents totaled $226.7 million as of June 30, 2019. During the quarter ended June 30, 2019, Myovant Sciences raised net proceeds of approximately $134.5 million from an underwritten public equity offering and approximately $2.5 million from its "at-the-market" equity offering program. Myovant Sciences currently has approximately $10.4 million of capacity available under the "at-the-market" equity offering program that it initiated in April 2018.

About Relugolix
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. Myovant Sciences has successfully completed two Phase 3 clinical studies (LIBERTY 1 and LIBERTY 2) evaluating relugolix combination therapy (relugolix 40 mg plus 1.0 mg estradiol with 0.5 mg norethindrone acetate) in women with heavy menstrual bleeding and uterine fibroids and is studying relugolix combination therapy in two Phase 3 clinical studies (SPIRIT 1 and SPIRIT 2) in women with endometriosis-associated pain. Data from SPIRIT 2 and SPIRIT 1 are expected in the first and second quarters, respectively, of calendar year 2020. Relugolix also lowers testosterone in men, an androgen known to drive the growth of prostate cancer. Myovant Sciences is evaluating relugolix, 120 mg once-a-day, in the Phase 3 HERO study in men with advanced prostate cancer. Top-line results from the HERO study are expected in the fourth quarter of calendar year 2019.

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 study in healthy female volunteers to characterize the dose-response curve in a minimal controlled ovarian stimulation setting has been completed.