Myovant Science Ltd
Myovant Sciences Ltd. is a clinical-stage biopharmaceutical company focusing on developing and commercializing therapies for women’s health and endocrine diseases, including prostate cancer. The company’s lead product is Relugolix, an oral, once-daily, small molecule that acts as a gonadotropin-releasing hormone receptor antagonist for the treatment of heavy menstrual bleeding related with uterine fibroids, endometriosis-associated pain, and advanced prostate cancer. The company was formerly known as Roivant Endocrinology Ltd. and changed its name to Myovant Sciences Ltd. in May 2016. The company was founded in 2016 and is based in Basel, Switzerland.
Relugolix is an oral, once-daily small molecule that acts as a gonadotropin-releasing hormone, which includes luteinizing and follicle hormones. These are gonadotrophins because they stimulate the gonads – in males, testicles, in females, the ovaries. Myovant is developing Relugolix 40 mg for the treatment of heavy menstrual bleeding associated with uterine fibroids and for pain associated with endometriosis, and Relugolix 120 mg as a monotherapy for prostate cancer. They are essential for reproduction, which is critical as Myovant is the first of its kind in this space to have the efficacy they did.
Financially, the company is burning cash. In FY19 ended 3/31/19, the company reported a net loss of $273,600. This is not uncommon for early-stage biopharmaceutical companies. Often, monthly cash burn can exceed $500,000. However, the company posted promising results earlier last week. The company currently has ~$130M of cash on the books. The company has no short-term debt, and long-term debt has gone down from $97M in 3Q2019 to $92M in 2Q2020 (Q2 end of 9/30/19). The company continues to issue stock in order to raise capital to fund operations. In FY2019, Myovant raised $220M through an issuance of common stock, and $54M through a debt issuance.
On November 18th, Myovant came out with big news. Their lead asset, Relugolix, passed their Phase 3 tests, meeting their primary efficacy endpoints, with 96.7% of men achieving sustained testosterone suppression levels through 48 weeks. Further, Myovant reached all six secondary endpoints in men with advanced prostate cancer, with all p-values < 0.0001 (statistically significant). Myovant has plans to file a New Drug Application with the FDA as early as 2Q2020, on the heels of these strong results, with eventual expansion overseas in Europe and Japan.
Neal Shore, M.D., Medical Director of the Carolina Urologic Research Center, had this to say about Relugolix’s strong results, “An oral gonadotropin-releasing hormone, or GnRH, antagonist for advanced prostate cancer has been an aspiration for many years,”, and “If approved, Relugolix would become the first-of-its-kind oral option for men with advanced prostate cancer.”
While the company has received positive feedback, it is still under extreme financial duress. For the company to turn a profit, count on receiving their New Drug designation or being acquired by one of the bigger players in the pharmaceutical industry. It will be interesting to follow Myovant and Relugolix as they make their trek to save more lives.