MYOV near term catalysts and why I value the stock as I do. This quarter they will release top line data from the only ph 3 they need to validate Relugolix for prostate cancer treatment. I've detailed how this same drug works to help women with uterine fibroids as well as endometriosis. Same reason here.The sex hormones of both sexes are controlled by the hypothalamus. It tells the pituitary gland when to release leutenizing hormone(LH). For women this leads to release of estrogen in men to Testosterone. Relugolix is an antagonist to this. It prevents release. All early treatments were agonists I.e. Birth control pills-they create short term increase in estrogen, then a drop. Just not enough of a drop so women still have excessive bleeding etc. Lupone injections work for both sexes but drives reaction too far. For women puts them in temporary menopause with all the consequent symptoms. For men it works best later in the treatment paradigm when faced with castration resistance. Add on that it is $1550/quarter. Relugolix will be in $150-200/month with no doctor visit. In men it works against hormone induced prostate cancer, which is early stage which is majority of pick ups. In a man, his Testosterone level is too high leading to a high PSA test result. Taking Relugolix in the phase 2 study quickly dropped the Testosterone level as well as the PSA and is quickly reversible. No reason to think same result will not happen in the phase 3. That is again the primary endpoint. Secondary endpoint which would be really huge is time to castration resistant treatment which is pretty much the worst case scenario. If it can delay that further it becomes an even bigger blockbuster. Men get prostate cancer. Often not treated much as can outlive such a slow moving cancer. If can contain the problem with an oral med that is safe and reversible(patients can take a short holiday allowing Testosterone back-takes too long with Lupone), then urologists will be heavy scribers. So where are we then. MYOV we know will be submitting NDA for Uterine Fibroids before end of year. Competitor Elugolix has had an awful launch as has significant safety issues. Lupone also has issues and involves quarterly doctor visits with depot injections and far more expensive and brings on bone density issues and menopausal symptoms. Reglugolix is 10x more potent then Elugolix with a MUCH longer 1/2 life(effectiveness). MYOV looks at this treatment as a bridge to menopause, as it has proven safe,relieves symptoms,and problem goes away at menopause. So a chronic problem with long term treatment creates a mega-blockbuster. Marketed to Obgyn's who want to improve quality of life of patients. As far as prostate cancer, if results hit primary endpoint endpoint filed early 2020 and like for Fibroids expect a year till approval. Also should be blockbuster as safest treatment for early on hormone induced prostate cancer. Next you have Reglugolix for endometriosis. Phase 3 readout come Q1 and Q2 2020. Should be similar to uterine fibroids trials. If so NDA filed 2H 2020. Next point becomes Sumimoto Pharma buying Myov along with 5 other Vants with 6 options on vants and rights to Roivant tech platform. Their cash cow drug goes off patent in a few years and they just discontinued trials on what was to be its replacement. They are taking out a short term loan to close the MOU and look then for longer term financing. They could not find a fairly priced future blockbuster in their field of neurology. Listen to their MOU conference call and hear from company and big time analysts their extreme need for BIG TIME revenues in 2023. This MOU should close by end of October, and will give them 47% of MYOV. I expect them to want it all. Sumimotoalready have offices in the US and I am sure they see the peak sales way out of whack with a Market Cap under $500M with at least 2(if not3) blockbuster potential indications. Relugolix was purchased from Takeda by MYOV along with a female fertility drug in phase 2 which appears promising. Hits my sweet spot of significant derisking, yet huge upside.
