Best guess is that we are headed into a 6 month or so period of lesser share price uncertainty for SYN. Day to day it will still be unpredictable, but as we near the January completion date of the pivotal Trimesta RRMS clinical trial, the share price seems likely to climb on the better than even chance of positive results. From January until the study is reported, we can expect greater volatility as trader's impute advance knowledge into every fluctuation. Reaction to the results to be anticlimactic. Maybe see some dips even on positive results as the implications of the expense of phase III, NDA, and the meager cash on SYN's balance sheet worry investors. If significant efficacy is not shown or there are adverse events, the stock will not totally crater because there is still the infectious disease pipeline, but there will be carnage. What am I missing?
These posts should probably be read in reverse order. Also something I would like your thoughts on is the development route for Trimesta. What we've seen with flupertine and the Intrexon venture products is developmental costs being financed with equity in the company and rights to profits from the products. While the $10MM on the books will be enough to keep a heartbeat in the company, it will not be enough to finance Phase III and NDA for Trimesta. The big difference between Trimesta and flupertine and the Interexon products, is that the phase II study was financed with $8MM in grants from Southern California Chapter of the NMSS and the NIH. It didn't cost the company equity or future profits in the product. I think that if the results are positive, (a likely outcome, but how positive we don't know), there seems to be a chance that further grants will be received for funding at least some of the further development, thus safeguarding more of the company's equity and future profits from the product to EXISTING SHAREHOLDERS. I question whether this possibility is priced into the share price currently. I have seen disease charities through a lot more money at a lot more speculative therapies. The CFF funding of liprotamase comes to mind
Probably nothing happening over the next 6 months, but there's Flupirtine (at Meda) which is in Phase II. SYN will profit, assuming positive results, when NDA is filed, FDA approval, and ongoing royalties.
According to Morningstar, they have about $10M in cash, which should maintain current operations for approximately 12 months.. Please correct me if this is wrong.
Does anyone know if they still operate the lab -- formally known as Adeona Lab and Hart Lab? In the past, this provided a modest income stream.
Trimesta is much further along the road to approval and launch than flupertine. Also the milestone payments for flupertine are pretty modest. $5 million upon the FDA’s acceptance of NDA for flupirtine for fibromyalgia and $10 million upon FDA approval of the NDA. The real money made there would be in royalty income, but we are talking 5-7 years optimistically. The good news on flupertine is that the development will be funded by Meda.
Effective March 8, 2012, SYN executed an Membership Interest Purchase Agreement, and certain related agreements, in which they sold Adeona Clinical Laboratory (the “Lab”) to Hartlab, LLC, an entity controlled by the Lab’s former owner, Narayan Torke, for (i) the immediate assignment of the Lab’s outstanding accounts receivable plus (ii) $700K payable pursuant to a two-year promissory note secured by all of the assets of the Lab. So far as I know the note is not in default. The note and all unpaid interest are due March 1, 2014. The balance sheet for March carries the $700K note receivable as an asset.