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I can explain it to you. I can't understand it for you.
but hey, read up & don't just take my word for it:
(quote): "...Synergy Pharmaceuticals Inc.is starting two Phase 3 trials with its constipation drug candidate, plecanatide, which would be a competitor to Linzess. Does that put pressure on Ironwood?
GM: Our view is that it doesn't, for a couple of reasons. The first is that the theoretical differentiation for the Synergy drug was that it would have a lower rate of diarrhea, which is one of the most common adverse events with Ironwood's Linzess. The efficacy was presumed to be equal. What we know now, from Phase 2/3 trials, some released last year, is that for diarrhea, plecanatide looks largely similar. It is not differentiated in that respect. Its efficacy is not exactly equal. It's going to be difficult to market a drug like plecanatide in a primary care setting when it isn't any different from Linzess. ..."
quote from:
http://www.hispanicbusiness.com/2014/5/16/j_p_morgan_s_geoff_meacham.htm
no chance whatsoever for that.
quote :...."TLSR: Ironwood certainly has the first-mover advantage, and Synergy is probably looking forward at least 24 months before plecanatide could be on the market.
GM: I agree, though Synergy's drug may take longer than 24 months because the company still has to do a large Phase 3 trial. Also, Ironwood has several thousand patients in a safety database, and Synergy has that to do as well.
from May 16, 2014 J.P.Morgan investor conference / interview, see:
http://www.hispanicbusiness.com/2014/5/16/j_p_morgan_s_geoff_meacham.htm
LOL. feel free to mark my posts for later reference, grasshopper :)
this is interesting: as of today, Nasdaq reports the institutional ownership of IRWD as 111%
http://www.nasdaq.com/symbol/irwd/institutional-holdings
IMHO, this is in line with the ongoing hedge fund short covering as of late (see I-Box); the public IRWD float is so small, that they have to temporarily borrow from institutions to cover.
in case of unexpectedly or better than expected news, this could provide for a nice short squeeze...
good read:
http://www.investopedia.com/ask/answers/07/institutional_holdings.asp
near term event: 2Q Earnings Call on Aug 4th:
http://finance.yahoo.com/news/ironwood-pharmaceuticals-host-second-quarter-200000816.html
IP situation: posting my earlier reply from Cafepharma to another overly optimistic plecanatide IP spin post - enjoy.
Quote:
Originally Posted by Anonymous
IP agreement with IRWD blocks competition. Despite the company’s patent–license agreement with Ironwood, there’s still some investor belief that an intellectual property overhang exists on the stock, thus, the company’s plecanatide patents are worth touching on. The patent deal with IRWD, announced in September of 2012, actually blocks other companies from entering into the GC-C agonist segment and competing in the key IBS-C or CIC indications, or any other inflammatory GI diseases or cancers with the technology. As a result, for large companies hoping to enter this drug class, SGYP is the only asset available for acquisition or partnering and this is why the company is likely to be on analyst take-out lists this year. Synergy has two patents covering the composition of plecanatide – one is a broad patent covering several analogues of uroquanylin (the parent structure of plecanatide), and the other is a patent covering the specific structure of plecanatide itself. These patents, with Hatch Waxman exclusivity, are expected to expire in 2025, and the company continues to evolve its patent estate.
Plecanatide is an analogue of uroquanylin, with one amino acid different from the active form of uroquanylin. The replacement of aspartic acid with glutamic acid fixes the structure in a rigid (partially closed) state, which was designed to act in the intestine and is more stable and more potent than uroquanylin. This novel peptide structure was also designed for optimum low-cost manufacturing.
Ironwood obtained a patent on the use of plecanatide in IBS-C and CIC after multiple rejections by the U.S. Patent and Trade Office (PTO), but of course, Ironwood cannot sell the product in these indications because plecanatide (its composition of matter) is owned by Synergy. Synergy never applied for this “use” patent, as it believed the chance for issuance was low, and even if issued, the patent might not provide much protection. Nevertheless, Synergy licensed the patent from IRWD in order to cease litigation, but the company reserves the right to challenge its issuance per the license agreement. As a result, Synergy owns its initial composition of matter patents on plecanatide and has complete freedom to market plecanatide in all indications with the benefit of the IRWD license agreement. Should SGYP decide to challenge and successfully invalidate the use of the patent held by Ironwood, it will not be obligated to pay the “low-single-digit” royalty to Ironwood per the license agreement. Either way, Synergy’s IP on plecanatide remains strong."
Reply:
"You're spinning very hard here. a couple of comments:
- "large companies hoping to enter this drug class, SGYP is the only asset available for acquisition or partnering"
If you take off those rose colored glasses just for a second here - large companies are not exactly tripping over themselves to partner with (let alone aquire) SGYP, are they now ?
Judging from their obvious lack of interest, perhaps there's not quite as much to like about plecanatide than you optimistically assume here, yes?
After having a long, hard look at your molecule, maybe they'd rather develop their own GCC agonist after negotiating a (likely much cheaper) non-exclusive licence deal with IRWD on its' broad method of use patent, no ?
- "Plecanatide is an analogue of uroquanylin, with one amino acid different from the active form of uroquanylin."
You must have your head in the sand assuming this IP would not be subject to an obviousness challenge.
Surely you know that the aspartic acid - glutamic acid amino acid replacement is one of the most commonly found conservative single amino acid changes in natural proteins across species ?
Case in point: the guinea pig uroguanylin sequence, when compared with human uroguanylin, is "nature's precedent" of the same key amino acid change that Synergy scientists used to create plecanatide: exchange of ASP-3 with GLU (comparison to the human uroguanylin amino acid sequence, see: S. Yuge et al., J. Biol. Chem. 2003, 278, 22726-22733).
In light of those facts, the known structure of Uroguanylin alone may provide a reason for one of ordinary skill in the art to choose the claimed species or subgenus from the genus, based on the reasonable expectation that structurally similar species usually have similar properties. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also Deuel, 51 F.3d at 1558, 34 USPQ2d at 1214 (“Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.”)
www.uspto.gov/web/offices/pac/mpep/s2144.html
Solid ground IP-wise? no way, Jose.
If a generic company would pick the right juridiction / judge, you'd be on thin ice, at the very least.
Obviously, this must have crossed SGYP managements' minds, at some point. Why else start development of a very similar "me-too" (SP-333) with TWO addtional changes (D-amino acid replacements), if not as an "IP-waterproof" back-up to plecanatide ?
Looks like they got some good advice from a consultant, but a little too late. Now they're stuck with the frontrunner that folks don't seem to like and/or have doubts about, and time + money is running out. In my humble opinion only, of course.
which one to cut, which one to keep - decisions, decisions....
a couple of other sample posts from Cafe Pharma on the "best of class drug" that SGYP owns 100% :
"wake me up when plecanatide shows improvements based on the same measures used in linaclotide trials. There's a reason why the rates of diarrhea are so low, it's because the dose of plecanatide used in early trials isn't having significant impact on efficacy measures."
"phase II/III CIC data and almost complete with another phase 3 study. You should google Plecanatide and Dr Miner and educate yourself about the soon to be market leader. All physicians will care about, is 50% less diarrhea than Linzmess with Plecanatide.
Googled Dr Miner and plecanatide, what were the rates of diarrhea for the 0.3, 1.0 and 3.0 doses of plecanatide?
Interesting when you present the efficacy data for the 3.0 dose but the tolerability data for the lower, less efficacious doses. If this drug was going to be a blockbuster, a big pharma company would have initiated a partnership or bought it already."
as you can see - it's not just me - there are quite a few people who are not very optimistic about plecanatide's potential.
Also, immunogenicity could be an issue. Remember, only one amino acid in plecanatide is different from the human body's own, natural GCC agonist uroguanylin. Especially because it's a conservative amino acid change (Glu replaces Asp) that preserves shape & charge, cross-reactivity between anti-plecanatide antibodies & endogeneous uroguanylin would not be unexpected. As you can imagine, ANY SIGNIFICANT cross-reactivity whatsoever, and they would be up sh$t creek without a paddle...especially if the FDA would ask for it as a PRE vs. a POST marketing requirement(compare: http://www.anptinc.com/index.php?option=com_content&view=article&id=164&Itemid=129)
These are the type of hard questions that potential partners would ask.
To the keen observer, the absence of any partnership / buyout offers speaks loudly....
you're paying attention to the wrong things. I'm reposting what I posted on Cafepharma earlier in response to a similar post:
"LIQUIDITY AND CAPITAL RESOURCES
As of March 31, 2014, we had approximately $20.6 million in cash and cash equivalents and approximately $50 million in available for sale securities, compared to approximately $18.1 million in cash and cash equivalents and approximately $50 million in available for sale securities as of December 31, 2013. Net cash used in operating activities was approximately $20 million for the three months ended March 31, 2014, as compared to approximately $15.6 million during the three months ended March 31, 2013. Approximately $ 22 million was provided by financing transactions for the three months ended March 31, 2014, and $4.6 million for the three months ended March 31, 2013. As of March 31, 2014, we had working capital of approximately $63.6 million, as compared to working capital of $56.2 million on December 31, 2013."
thats verbatim from the latest SGYP 10Q filing (May 12, 2014), check:
http://secfilings.nasdaq.com/filingF...12%2F2014&pdf=
so only ~$71 mill in cash&ATM facility (CantorFitzgerald) shares for sale at the end of 1Q 2014.
assuming a similar burn rate as they stated for 1Q 2014 (~20 mill), they'll run out of money around sometime in 1Q 2015; - in reality probably sooner due to the added burden of two additional Ph. III trials that start after the filing (2nd Ph. III CIC-trial [2Q 2014]+ IBS-C Ph. III trial "expected to start in 2H2014").
sale of the company ?? LOL. wouldn't institutional investors be all over them?? yet, their institutional ownership is only ~29%, hasn't really moved much at all.
check : http://www.nasdaq.com/symbol/sgyp/in...ional-holdings
Likewise, wouldn't the hedge funds want to reduce their short positions if the writing of a sale is on the wall ??
yet, the short volume for SGYP (~7.9 mill. shares at EOY 2013) just keeps climbing and climbing, and has in fact doubled since 12/31/13: 16.2 mill. shares as of 05/15/2014). looks like the hedge funds bet on this going down the drain....
check: http://www.nasdaq.com/symbol/sgyp/short-interest
IRWD loan: did you actually check what happened to IRWD share price when they announced the their $ 175 mill loan (see: http://news.ironwoodpharma.com/Press-Releases/Ironwood-Completes-175-Million-Debt-Offering-82.aspx) ?? the stock price had the biggest run in the company history !
Clearly, the market was pleased that someone was willing to lend the company such an amount of $$, non-dilutive ! (see: (http://news.ironwoodpharma.com/Press-Releases/Ironwood-Completes-175-Million-Debt-Offering-82.aspx).
Compare that to Synergy : haven't found any announcement from them on non-dilutive loans the kind of that IRWD secured ?? & their institutional shareholders are obviously not willing to sign up for a secondary offering - that's why they have to sell (& dilute) via the CantorFitzgerald share sale facility on the open market, at gradually lower and lower prices...
The largest 7 institutional shareholders in IRWD have each invested ~ $ 100 million or more; the largest one even close to $ 300 million ! (compare: http://www.nasdaq.com/symbol/irwd/institutional-holdings)
Compare that to Synergy: there are only 4 (!) institutional investors with more than 10 million in Synergy LMAO ! (18.121 million for the largest). http://www.nasdaq.com/symbol/sgyp/institutional-holdings
Even you will have to agree - smart money doesn't exactly buy the "best in class drug" company fable, do they ?? ROFL
Thank you though for your kind encouragement to comment on their IP position. Will write on that in a separate post.
They'll still own 100% going into Chapter 11, too.
Congratulations!
as of 06/30/2014, Synergy's (SGYP) short volume (~16.2 million shares) overtook Ironwood's (IRWD) short volume (~13.5 million shares)...
(per NASDAQ website):
http://www.nasdaq.com/symbol/irwd/short-interest
http://www.nasdaq.com/symbol/sgyp/short-interest
short volume updated (see I-Box).
interestingly, as of 06/30/2014, Synergy's (SGYP) short volume (~16.2 million shares) overtook Ironwood's (IRWD) short volume (~13.5 million shares)...
(per NASDAQ website)
http://www.nasdaq.com/symbol/irwd/short-interest
http://www.nasdaq.com/symbol/sgyp/short-interest
For what it's worth; I contacted the court-appointed receiver (Duff&Phelps in Canada) & was advised that the proceedings have been completed. The outcome was that the mining assets were foreclosed upon by the secured creditor. There are no assets remaining in the USC entity.
whoever wants to read up, can find the details here:
http://www.duffandphelps.com/intl/en-ca/Pages/RestructuringCases.aspx?caseId=933
Hale Capital Partners (the secured creditor) acquired all the assets & now owns the Crescent Mine through its subsidiary 'Crescent Silver LLC':
http://www.marketwatch.com/story/hale-capital-partners-announces-acquisition-of-substantially-all-of-the-assets-of-united-mine-services-inc-2014-04-22
there is really no reason why the PPS should sit this low, given the asset & PEA they're sitting on, IMHO. a time to accumulate & be patient, IMHO.
better to buy this one on the Canadian exchange (FNR.V); - volume on the OTC market is practically non-existent
never mind. book value $ 2.7 in early 2013, thanks for digging this up & posting it.
A Gold report analyst thought along the same lines in 2012.
The Gold Report
Posted: May 30, 2012
Expert Analysis
Greg McCoach, Insider Alert (5/18/12) "Shares of 49 North Resources Inc. have held up better than most other junior mining companies. . .this company represents great value. . .we are currently trading at $2.55, which is a great price when you understand the quality of assets that the company holds in its portfolio. This is a company I am looking to build over the summer. . .49 North is a Buy."
http://www.fnr.ca/html/fnrnews/whats_new/index.cfm?view=article&wnID=104
do you recall what the book value was when you posted this ?
just got in in time. are you still in? I really like this nicely balanced Saskatchewan resource story.
agree. just sayin....
look at the conditions of the CVG sale to Omineca & what the seller (who then took over the majority of Omineca as part of the transaction) was willing to accept. the unsecured debenture conversion trigger levels are especially intriguing, IMHO.
that is the only reason I haven't dumped yet. Currently, I place zero value on both the remaining Labrador claims & the security app venture.
have written to the company about this. IMHO, this is probably the least of their worries right now. very hard to raise money at their current PPS level. their most likely avenue of success, if any, lies in the Cariboo, IMHO, where they own a bunch of claims on the other half of the mountain across from CVG Mining. that company was bought out by Omineca Mining last year, if you recall. perhaps a chance for a JV there, it would certainly make sense, given the undetermined origin of the placer gold in that area. all in my own humble opinion only, of course.
great find, Dobie. thanks for this. hence the annual payments to the Pescio family in the 10Q. it does sound rather promising, for the patient ones among us, at least, IMHO.
really like the new drill data. this is looking better and better. a real keeper, this one, IMHO.
this may be a good time to average down. they were able to close the PP; with substantial insider participation, too.
update: of the last remaining 16 Wolverine Exploration Labrador claims in good standing, another 10 were cancelled today (no work report submitted):
http://gis.geosurv.gov.nl.ca/mrinquiry/License.asp?License=017584M
now Wolverine Exploration has only six Labrador claims left in good standing (150 ha total):
http://gis.geosurv.gov.nl.ca/mrinquiry/License.asp?License=013472M
agree. on paper, they seem to have accumulated some promising properties. unfortunately, it looks like the money ran out for exploring them...
don't know if you saw this:
all the 'cache river' claims have been given up; see Labrador/Newfoundland Dept. of Natural Resources website link : http://gis.geosurv.gov.nl.ca/mrinquiry/mrDisplay.asp
The claim groups where most of the geological knowledge was acquired / i.e., where most of the exploration $$ was spent, were all abandoned (e.g., claim group 012425M: $194,864.34 spent; 017521M: $69,869.43 spent; 013187M: $72,131.82 spent; 013039M: $436,493.50 spent).
out of the original 609 mineral claims, >97% have been cancelled.
Only 16 claims(Hamilton river)remain in good standing as of June 2014 ; work reports on those are due next month.
note: I-Box update (with up-to-date short volume numbers).
short volume has been consistently decreasing since the end of last year, from ~22.4 mill to ~15.2 mill, as of 06/13/2014.
hedge funds less comfortable with their large short positions here ??
IRWD broke through the previous 52wk high yesterday.
The number of Labrador claims has come down quite a bit since that was published, according to the Labrador mineral titles website. There are claim reports due next month for both the Eastern & Western claim groups. I'll keep an eye out for them & report here once they come out.
here's another noteworthy quote from that article:
(quote): "...Synergy Pharmaceuticals Inc.is starting two Phase 3 trials with its constipation drug candidate, plecanatide, which would be a competitor to Linzess. Does that put pressure on Ironwood?
GM: Our view is that it doesn't, for a couple of reasons. The first is that the theoretical differentiation for the Synergy drug was that it would have a lower rate of diarrhea, which is one of the most common adverse events with Ironwood's Linzess. The efficacy was presumed to be equal. What we know now, from Phase 2/3 trials, some released last year, is that for diarrhea, plecanatide looks largely similar. It is not differentiated in that respect. Its efficacy is not exactly equal. It's going to be difficult to market a drug like plecanatide in a primary care setting when it isn't any different from Linzess. ..."
quote from:
http://www.hispanicbusiness.com/2014/5/16/j_p_morgan_s_geoff_meacham.htm
I really like this one. got a starter position last month after they were able to secure the Mugor royalties. the trading range / NAV is ridiculous. a gift from above; - in my humble opinion only, of course.
I guess "we see how this unfolds" right about today, yes ?
Ironwood Pharmaceuticals, Inc. (IRWD) will present a corporate update at the Goldman Sachs 35th Annual Global Healthcare Conference on Wednesday, June 11, 2014 at 2:00 p.m. Pacific Time/5:00 p.m. Eastern Time:
http://investor.ironwoodpharma.com/events.cfm
I'm in. hope it stays in this range a little longer. highly diversified asset base, a gift from above at these levels IMHO. like them even more since their Omineca reverse takeover deal.
I don't think so. I know who's neighboring the new claims they staked less than a month ago & the plot thickens, in my humble opinion only, of course.
Haven't checked the Labrador claims lately; but as far as BC is concerned, I found 25 mineral titles for Wolverine Exploration on the MTO website; 15 of them expired as of last month. The remaining 10 are in good standing until Feb-May 2015:
https://www.mtonline.gov.bc.ca/mtov/searchTenures.do?owner=277798
The one detail I found intriguing, however, is that at the bottom of the claim list, the last five are new claims that were added in the spring of 2014.
On the other hand, the first five claims in the list seem to be part of the package that was acquired in 2013 with the Cariboo deal & are still in good standing due to exploration work carried out on them in Aug 2013. Quote : "Work Type Technical Work (T)
Technical Items Geological (G), Geochemical (C), Prospecting (PR) ", see:
https://www.mtonline.gov.bc.ca/mtov/sowEventDetail.do?eventID=5478756
not sure what that means. maybe they found something of interest after all during the 2013 "geological/geochemical/prospecting" ? why else would they all of a sudden stake new claims in the neighborhood as recent as last month??
very shortly after the underwater Tangiers notes have been modified
wasn't able to find a transcript of the May 30 JP Morgan conf. call, but they did confirm their 'overweight' rating for IRWD ($22 price target) earlier last month:
http://zolmax.com/investing/ironwood-pharmaceuticals-receives-overweight-rating-from-jpmorgan-chase-co-irwd/257386/
subpennies first
Ironwood Pharmaceuticals Stock Rating Upgraded by Bank of America (IRWD)
http://tickerreport.com/banking-finance/195849/ironwood-pharmaceuticals-stock-rating-upgraded-by-bank-of-america-irwd/
broke through both the 50 and 200 day moving averages last month
Tombstone Exploration is, IMHO, a very "mild" preview of what will happen here once we secure the initial round of funding for the 1st stage drilling program