$heff's $tation of $tocks & $olid DD

[ash111]

SPHS DD(inside),Session Schedule: Tuesday, Feb 9, 10:00 AM - 10:30 AM – Park South
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Genesis13 Monday, 02/08/16 06:46:27 PM
Re: None
Post #
1506
of 1512 Go
Management

CEO- Randall woods, was CEO of Novacardia which he sold in mid stage phase 3 trials to Merck for 350 million in 2007. In 2003 his company Corvas international was acquired by then Dendreon for 100 million which was highly growing at that time.
Has 20 years experience at Eli Lilly & Company in sales and marketing. He's a guy that knows how to negotiate deals and build buyout target companies with great science.

CFO- Peter Slover, was Cfo at anadys pharmaceuticals inc, which was bought out for 230 million in 2011. Had other major positions there as well.

The management as a whole have brought 20 drugs to fda approval.

Stock information/Data Results

There IPO in the United States was in the summer of 2013 during when they changed their name from protox to sophiris (because it confused people with Botox)and moved to la Jolla California as well as hiring the management team above in 2012.
The chart really starts in mid 2013 in which they iPo’ed at 5 a share. In December of 2014 they released interim results(share price was 2.80 then) on their phase 3 trials for drug prx302. The results indicated a failed statistical efficacy at just 3 months. Stock fell 80% on meaningless fear, being their primary endpoint was reached in November of 2015. The drug needs time for its science to work, which is a protein that kills cells specifically injected into the prostate gland. At 12 weeks you cannot justify it’s a fail but wall st speculation can, bringing it to .50/share. Eventually the final results were statistically efficient with a 7.60 ipss score vs 6.58 placebo. A 1 pt efficiency over placebo let alone even the placebo itself has higher ipss than oral drugs on the market currently shows it”may be sufficient enough for registration with the FDA” according to COO Dr. Allison Hulme. The managements history in my opinion know what is and what's not eligible for fda acceptance, and hint these results are indeed eligible. Even better at the 18 week mark only 6 weeks after it was deemed a failure, that's when the drug held its most efficient efficacy.stock soared to a high of 3.85 after results and have sold off and consolidated to 1.60-1.70 as of today. Imo for a stock with only a 25-30million market cap this is absurdly undervalued for positive p3 results and only need one more clarification trial for approval. As well their science is being used for a phase 2 trial in which the same science kills prostate cancer cells. They specifically inject the drug into low risk prostate cancer candidates directly into tumors. The science kills cells safely so Imo being directly injected into tumors this phase 2 will be a success which is due within the end of june.Low float stock it can double on that upcoming catalyst. If their p3 interim results hypothetically didn't exist the stock should be 6-7 based on the fact nothing changed really.

Competitor Nymox Pharmaceutical

There competitor nymox pharma(NYMX) imo is a charade. They have a very similar science but haven't exposed it due to “proprietary reasons”. There management doesn't come close to sophiris management and track record. They have 2 failed p3 trials that cost money diluting the company severely over those years. They have 43.5 million o/s compared to sophiris being 16.2 million. Sophiris 3 times less diluted than their competitor and trading at a measly 25 mil cap, NYMX is currently trading at 93.78 million market cap, on two failed p3s and filed an extension trial that happened to succeed. Imo being sophiris in there last 10-q said that two positive p3 trials are generally required for fda approval. Sphs has 1 nymox has 2 failed ones, a positive extension trial imo means zero. They are a PR machine as well and I like companies that do there talking based on results and actions and I like the quietness from better managed sophiris. Another red flag , they have a cease trade order going on in Toronto being there as well a original Canadian company like sophiris. A cease trade is concerning. Another red flag is they have moved there headquarters to the Bahamas. iMo no legit and serious corporation would ever move to the Bahamas, they plead its for tax reasons. Another red flag is a newly appointed director James Robinson just so happens to be buying million of shares in the open market. Stock price rose during the spring to now because of that and fooling shareholders into thinking it’s a winner being why would he just throw his money away, but there red flags shows it's could be a scam to promote the stock. Other accounts can be shorting it we do not know of. The most concerning red flag to me is in there sec filings, they never directly tell their shareholders that they plan to file an nda with the fda in the U.S., and say that they will “file wherever possible”, meaning Imo that they know with there data on hand it's not good enough for fda approval in the United States. Another red flag is its requires one million dollars to file admission with fda, in their latest 10-q which happened to be months delayed(red flag) showed they have only a measly 100 k left. This hints dilution down the near road to an already diluted company, Imo big pharma would rather buyout or partner with sophiris that's trading at 25 mil with better management, track record, value and fda requirements. NYMX is a charade and is leading on their investors into thinking they can file with just a positive extension trial. No big pharma will want to do business with a sketchy run NYMX.( let alone sophiris is a bargain at 25 mil) 1 more thing is Sophiris drug is modified scientifically to work only in the prostate being if misused wouldn’t cause problems unlike nymoxs drug, which isnt modified so if drug leaks out theres issues and safety is a number one.

Upcoming catalysts

Sophiris' p2 trial due Around june is bound to succeed being they directly inject their cell killing protein into tumors in low risk prostate cancer. There was a complete ablation which was very key because its a small trial. They are learning the best methods and amounts for tumor size showing safety is not a problem.once science is fully mastered this can pass a p3 with big pharmas guidance or if they buyout.There cash will only fund them until April 2016, leaving them with most likely a success p2 for prostate cancer and a second p3 trial. Big pharma will most likely buyout or partner with sophiris and give anywhere from 50-100 million upfront plus milestone achievements. With big pharma involved (which if I was big pharma this is an amazing opportunity), they will run a mass trial of 1000 patients plus, well managed to almost guarantee a statistical efficacy on their last p3 trial. Stock can double on successful p2 then even triple on a partnership press release in premarket, bringing it to around 6-7 a share. Imo this company is worth much more than the insulting 25 million. Realistically it should be worth at least 150 million based on my analysis and much more if FDA approves drug and make a minimal 200 mil/yr sales in BPH market. They are far much more superior to their competition NYMX for many reasons. Sophiris has 1 +p3, nymox has 2 failed p3s and 1 +extension trial that imo in they eyes of the FDA doesn't magically cover up the failed 2 p3 trials. Super undervalued biotech stock in sophiris that has a Ceo with an unbelievable track record known for making deals with big pharmas.