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SYN Informational Lunch Meeting with the Philadelphia Securities Association on
Monday, March 23, 2015
Social: 11:30am- 12:00pm
Luncheon: 12:00pm - 1:00pm
(originally posted on the YMB)
Very nice way to begin what should be a stellar week!!!
Also, new BUY recommendation from Columbine Capital that compares SYN's current $2.59 to industry peers currently ranging in value from $2.80 to $8.00. This seems to indicate we have a LOT more room to run!!!
which we all well knew!
Positive Phase Ia and Ib Data on SYN-004
More good news this morning!
Synthetic Biologics Announces Positive Pharmacokinetics Data from Phase 1a and 1b Trials of SYN-004 to Protect the Microbiome and Prevent C. difficile Infection
-- Supportive Evidence for No Active Enzyme Absorption into Bloodstream Observed in Phase 1 Studies --
-- Results Pave Way for Phase 2a Clinical Trial to Start this Month --
ROCKVILLE, Md., March 19, 2015 /PRNewswire/ Synthetic Biologics (NYSE MKT: SYN), a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced positive pharmacokinetics (PK) results from both the Phase 1a and 1b studies of SYN-004, which is being developed to protect the microbiome and prevent Clostridium difficile (C. difficile) infection.
"The PK data confirmed that SYN-004 acts as Synthetic Biologics intended. SYN-004 goes directly to the gut where intravenous (IV) antibiotics are excreted, with the intention of protecting the microbiome from a cascading set of events that often lead to potentially deadly C. difficile infections," said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "These data support our expectations that SYN-004 should have no effect on the IV antibiotic in the bloodstream, therefore allowing the antibiotic to do its job and fight the primary infection. We look forward to continuing the clinical evaluations of our lead candidate, SYN-004, with the initiation of a Phase 2a clinical trial this month."
The Phase 1a, single-ascending dose PK study provided data to support Synthetic Biologics' hypothesis that SYN-004 taken orally was not systemically available in the dose range tested. The PK data from this study measured blood levels of a single dose of SYN-004 in participants over a 10-fold dose range. Minimal levels of SYN-004 were observed in the bloodstream across the dose range investigated in the participants.
The Phase 1b, multiple-ascending dose PK study provided data to further support that SYN-004 is not systemically available, as no meaningful levels of SYN-004 were observed in the bloodstream after participants received multiple doses of SYN-004 four times a day over a seven-day period. The PK data confirm Synthetic Biologics' expectations based on previous data from the first generation enzyme (P1A).
In addition, no clinically significant safety events were observed, and both the single and multiple doses of SYN-004 were well tolerated by the participants of the Phase 1 studies. Synthetic Biologics intends to continue the clinical development of SYN-004 in a Phase 2a clinical trial to evaluate the ability of SYN-004 to degrade residual IV antibiotic in the gastrointestinal (GI) tract, therefore potentially protecting the gut microbiome and preventing C. difficile infection.
Currently, there is no vaccine or drug approved by the U.S. Food and Drug Administration (FDA) specifically for the prevention of C. difficile infection. The U.S. Centers for Disease Control and Prevention (CDC) has identified C. difficile infection as an "urgent public health threat" that occurs mostly in people who have had recent medical care with IV antibiotics. SYN-004 is intended to block the unintended harmful effects of antibiotics within the GI tract and maintain the natural balance of the gut microbiome, potentially preventing the 1.1 million C. difficile infectionsi and 30,000 C. difficile-related deathsii in the United States each year. Approximately 118 million doses of IV beta-lactam antibioticsiii that could be inactivated in the GI tract by SYN-004, were administered to approximately 14 million hospitalized U.S. patients during 2012.
This temporary takedown by those with an obvious agenda will be short-lived. Since we haven't had much by way of a real and thorough investment report, the speculators have taken over.
Well, now we have a real investment report -- and it pretty much says what we all know -- SYN is worth multiples over where it is. I particularly like the conservative LT valuation of over $19!!
Read it and buy all you can at these levels!
http://www.griffinsecurities.com/viewpdf.php?docid=973
FWIW, if there will be any more attempted takedowns, tomorrow is probably it. It's a Friday thing. It could go either way, but I think the bears will make at least one more attempt to push it down. How far and how long will depend upon the buying pressure that has so far been propping it back up. If folks read this report, there may be more buying pressure to come. Only so many days left to March. We should be hearing about c-diff any time now. Too many catalysts coming up to be on the sidelines with SYN. IMO
GLTAL
Hahaha, no one actually reads these boards for investment advice, do they?~!~ Probably not.
I expect Friday might be more of the same as well. But Q1 2015 should be very good. And if the right news comes out, that should carry through the year.
Happy New Year everyone!!!
I am pretty sure all the long timers here know that Pipex was very different from AEN and both of those very different from SYN.
The public company has remained, but it is three different companies with different goals.
SYN is now a Kirk company, with an amazing pipeline that never existed before. It has management with proven success in the biotech world. It is far from Pipex or AEN.
Let's keep it real, please.
I, for one, feel it is being manipulated -- possibly by that disgruntled employee so named in the yahoo message board. If not him, then others. It does feel very purposeful and for accumulation reasons. No matter -- I've accumulated right along with him/her/them!
2015 should be a very good year for SYN -- if the rest of the world doesn't fall apart!
Effirma is the brand name for flupertine, licensed to Meda AB. It is a non-opioid analgesic, already approved in Europe. It is being looked at as a different way to approach managing the symptoms of fibromyalgia. It has great promise for that indication, as well as other indications to manage pain.
This was a deal that occurred back in 2010, and as such, it is legacy, like Trimesta. I believe this is partly why Kirk bought in -- another potential cash cow. Those of us who have been around for a long time know about these 'hidden' gems.
http://www.pharmpro.com/product-releases/2010/05/adeona-and-meda-ab-partner-fibromyalgia-drug
It certainly seems SYN's dance card is full!
I think today is an attempt to get in before things go really crazy next week. Upcoming presentations in both Sept. and Oct. will draw attention to SYN. C-diff trial with topline results expected in Q4 as well.
This means we should have probable movement on both Trimesta and C-diff.
Then, there is pertussis and IBS. News any time.
Not to mention whatever is going on with Effirma over in Sweden that will mean milestone payments and royalties to us when the time comes.
Too many good surprises await SYN longs. Too risky to sell and be left on the sidelines when more good news hits. SYN will go from development to cash cow (multi-BILLION dollar opportunities!!!) in a blink.
IMO
Well now this is helpful!!
Fitch: Biologics Driving Revenue Gains for U.S. Pharmaceutical Companies
CHICAGO--(BUSINESS WIRE)--
Fitch Ratings expects that revenues from biologic therapies as a percentage of total pharmaceutical sales will continue to increase over the intermediate term as companies increase their prominence in their drug portfolios, according to a report published today.
Biologics drug sales for the six major U.S. pharmaceutical companies increased to approximately 36% from 27% over the last three years, as the number of FDA approvals has outpaced traditional small molecule approvals.
Fitch believes that biologics will fare better than small molecule drugs after patent expirations. The price discounts and market share gains of biosimilars will be less than those in the traditional generic market, because most approved biosimilars probably will not be automatically interchangeable with the original reference biologic early on. Nevertheless, Fitch believes biosimilar manufacturers, pharmacy benefit managers and drug distributors will have financial incentives to take share from the originator therapy.
Furthermore, the number of biologics in branded pharmaceutical companies' pipelines has and should continue to account for a greater portion of the number of total pipeline projects.
From a credit perspective, biologics are supportive for the credit profiles of the branded pharmaceutical industry by offering opportunities for growth, support for profitability and greater operational stability in the intermediate term…
Congrats longs!!!
Keep in mind, by rights SYN should be over $3 just by way of a correction. Had Kanzer not sold millions of shares to start his other business, we would not be where we currently are. IMO
I don't begrudge him his profits, but it certainly did not do the PPS any good in the short term.
The market also never understood Trimesta results. Sure, there wasn't the immediate payoff some anticipated, but the results were very, very good. The payoff off on the years of studying estriol is coming!
We have enough cash on hand to make it until a partnership is announced. And I think one will be.
Let's hope shorts and other manipulators don't suck away all the gains!!!
Remember, float is tight and getting tighter all the time -- working its way back from Kanzer's sell fest.
Currently Teva has a little breathing room because Copaxone is a complex formula -- so it's not easy to copy as a generic.
To me, the real benefit of Trimesta is on the cognitive side. I cannot wait to see the final results of the cognitive study. Interim results were already so good. This actually adds value to Copaxone and of course would extend the patent.
Of course, there is benefit in that Trimesta seems to help with relapses right away whereas Copaxone takes 8-12 months to show real benefit. But this benefit is probably not as much of an impact (on paper, that is, not to the patient who wants to feel better ASAP) as the cognitive improvement.
I think we see movement on Trimesta very soon.
Let's not forget Riley saying 2014 is SYN's year. We have a few months to go. Let's see if he was right.
The effect doesn't diminish over time. The Copaxone starts working.
No way the results could be interpreted to be bad without additional data. As an add-on to Copaxone on, it has great benefit.
In fact, from UCLA's site -- it all sounds very, very good.
http://newsroom.ucla.edu/releases/preliminary-clinical-trial-shows-great-promise-for-new-multiple-sclerosis-treatment
Folks are forgetting about its cognition benefits -- the NEUROPROTECTIVE benefits as well as the REPARATIVE benefits.
Sure, copaxone helps control relapses. But Trimesta helps 1) control them better, 2) starts working FASTER and 3)might reverse damage already caused by the disease.
Knock, knock who's there? Oh Teva, it's you!
:)
Really? How do we know this?
The PR said better by 32% at 24 months. I don't know the P-value here (we don't know it either for the 12 month mark) and these are topline results.
How do any of us know what the data detail will show?
This seems a huge market over-reaction to some folks claiming the primary endpoint failed. Nothing in the PR would indicate that.
I say a 47% at 12 months and 32% at 24 months would appeal to me if I were a patient. And I think it would appeal to Teva too -- coming off patent on Copaxone and seeing how this combo improves results.
I think those who were betting against SYN are really working it to make it tank. Looks like down is how it's going to go -- but I bet we see serious up again in the near future.
Holding on -- long and strong here.
What do you mean they missed the primary endpoint?!
"After 24 months of treatment, the reduction in relapse rate persisted in favor of the Trimesta plus Copaxone treatment group compared to the Copaxone plus placebo group (32 percent). Both treatment groups exhibited improvement in measures of cognitive function at 24 months. Treatment was safe and well tolerated with no evidence of adverse effects on breast or uterus."
Improvement at 12 AND 24 months -- 47 vs. 32% (12 versus 24) makes sense because Copaxone generally takes about a year to start working.
Let the losers spin away. These results are GREAT. I am sure there will be intested in Trimesta out there, for both patients and potential buyers.
Congratulations to longs! This is a success.
Trimesta WORKS!
Show statistically significant!!!
Yes!
Now...on to C-diff.
You know what, that's very possible. Either that, or simply doing a good job and wanting to put out some retention incentive (since they do take 3 years to fully vest).
The next week (and BEYOND) ought to be very interesting.
RB -- sorry, no PM. Double digits. :)
Good day, everyone! Are we having fun yet?!!
It takes cash to commercialize product and yet, SYN just cancelled an equity agreement. Why do you think that is? ???
There must be plans to make some money. A partnership or buyout perhaps? A placement (PIPE or otherwise) for far more money due to the impending PPS increase after Trimesta results?!
Any way you slice it, THIS cancellation combined with the recent stock options and salary increases bode very well for SYN. I have lots of confidence on this one. LOTS.
They are dropping the crumbs. Hansel and Gretel just have to pick them up!
Just saw this. Nice to have the mention, but very apparent as SYN is lumped in with all the others, the author does not understand how SYN-004 is supposed to work, right along with the antibiotics.
When folks stops freaking out about this hedge-imposed 'market correction', things will get back to status quo. Then, investors will look to who is providing value and doing real business. IMO
From Pharma Biz today:
PuraMed moves forward with the development of first cannabinoid-based medicine
Schofield, Wisconsin
Friday, April 11, 2014, 11:00 Hrs [IST]
PuraMed BioScience, Inc., a researcher, developer, and marketer of over-the-counter (OTC) medicinal and healthcare products, is moving forward with the development of their first cannabinoid-based formulation that targets the mental health market by focusing on anxiety and depression.
"We believe that with the technologies we have available, PuraMed can utilize hemp-derived compounds to build safer, more effective, and faster-acting treatments for a number of mental health conditions," said Russ Mitchell, CEO of PuraMed BioScience.
In 2012, mental health was the second largest US drug class for spending. In 2011, anti-psychotics and antidepressants accounted for $29.2 billion in US sales, with over 264 million prescriptions written for antidepressant medication.
However, studies show that 63 per cent of people who take antidepressants experience at least one side effect and 30 to 45 per cent of people fail to respond to antidepressant treatments.
"PuraMed's long history of building clinically effective herbal medicines truly sets us apart from the majority of other businesses entering the cannabis market," said Mitchell. "We believe we can be a leader in the development of a new generation of natural medicines that incorporate cannabinoids, which can deliver a superior level of efficacy without the severe side effects associated with current prescription drugs.
"We looked at the mental health aspect of development due to our migraine initiative with veterans who are also suffering with the effects of Post Traumatic Stress Disorder (PTSD)," said Mitchell. "Most common treatments for PTSD preclude use of commonly prescribed migraine treatments. It's a major problem for our active-duty military as well as our veterans. Movement into development of a mental health formulation aligns with our efforts to provide our service men and women with safer and more effective options which can enhance their quality of life."
Due to the lack of new research on new antidepressant medications and anxiolytics, we believe there is a strong need for advancement in this category. The process of formulation and prototype development is underway.
Hahahaah, 'joint venture' -- I love the double entendre!
This stock does seem to have potential, if folks would just quit flipping and let it rise!
Hm. Do they advertise or promote what they are in? How do you know of them? Are they in PMBS? This stock caught my eye today because of the rise in PPS. I don't know too much about it, only did a little DD, was wondering what was up.
Who is Beamin1 and wolf pack? Never heard of them.
Congrats to all on PMBS today!! Very nice day.
Awww, just saw this, thanks!
I hope I've helped some folks with their SYN analysis. I do feel I know the company pretty well, both pre- and post- Kirk.
I wish I had this confidence with ALL my holdings, but I'm a bit of a gambler at heart and a few of my equities are just a roll of the dice for me. My slot machines. Money I'm prepared to lose, but would love to see some 777s! :D
Gee, I hope not!!! Sounds painful!!
LOL
Nerves of steel here. I feel very good about all of my holdings. I took advantage of the sector selloff to adjust my biotech holdings. I picked up more SYN. I really cannot believe anyone would bet against this grossly undervalued gem. Folks who do are simply gamblers and have NO IDEA what the pipeline has in store. So many chances to score with this one, and at this price, what a steal!
Watch and see how it runs into the CEO's Monday morning conference call. Does anyone actually think he'll announce some 'bad news', on a Monday morning? If anything, it'll be neutral on the financials, show we still have cash due to the Kirk raise in December, and talk about the upcoming Trimesta results. IF we are lucky, we'll hear something on what he hinted at during the Roth conference -- news on pertussis that he said made him SMILE.
Gifts like this don't come around very often -- a huge selloff for NO REASON other than government interference. There is always a downside when they get involved with anything! Traders will forget about that Waxman letter soon enough and the sector can get back to business. The good stocks will rise. SYN is one of the good ones.
GLTA
Fools sold out. SYN will come back with a vengeance.
Everyone has been played in this and other biotechs as well. Played by the pros.
I hope the sideliners miss the run. It would serve them right for panicking and selling out.
Don't you see, he does that on purpose! He sells for HIS profit. Then, he tells folks about it. Then the sheeple sell because he sold. Then he gets to buy back at a lower price.
It's a beautiful thing.
FOR HIM.
I don't follow anyone else's recommendations -- though there certainly are a few out there that are GREAT counter-indicators. LOL
I bought here today. If I buy any more shares, Kirk will have to put me on the board!!! :D
I bought ISR yesterday in the low $2s and more again today.
I am feeling very good about buying the SCIENCE and not the sentiment of others. It always works out well for me because at the end of the day, I know what I own. Everyone else just gets to own tickers with no clue as to pipeline, or if they even have one, or anything about the financials, etc. It's just herd mentality. It's why these markets are so screwed up. And why you see good stocks [temporarily] tank when nothing has changed.
The saying 'the cream always rises' is true.
SYN is the cream.
Apparently he doesn't consider results out with conference call on a MONDAY MORNING with pertussis news hinted at that could come before April a catalyst.
Well, I do.
Took this opportunity to buy --- sold other gainers so I could do so.
You either flip this stock and follow others for pennies...OR
You know what you own, and why and have a plan.
Just stating the obvious, but some people really just don't know how to invest and are looking for others to tell them what to do. Those are the people that buy high and sell low to pad the gains of those who tell them what to do. Might as well go to the casino and take your chances on the slot machines, IMO.
GLTAL
Congrats to both the new and old holders of SYN! Today is a great day!!!
I think the Maxim $6 target is too low...then again, no one's asking me! Maybe they should be! LOL
Fun to watch. TG I bought more YESTERDAY!
Nice, you're already up!
This will head up all the way until the Trimesta results and hopefully explode up from there, if results are stellar.
After today, I'm tapped out for while, but I feel good with what I was able to pick up today.
Now for the popcorn. This is going to be a really good show!
Backing up the truck here folks...volume precedes price.
SYN is really on the verge of another serious breakout.
Soon, we'll be watching SYN trade in the $5s, before it takes off to double-digit-land.
Two upcoming catalysts - Trimesta results and pertussis update that Riley says makes him smile! Not many days left to buy at this level, IMO. I just moved some funds so I could snag some here. I'll be happy I did in a month or less!
Good luck, longs! This investment is just beginning to pay off. And we have a long, long way to go. Don't let the mms shake you out. They are notorious for that with SYN!
Buy, lock it away, and check back in a year! That's my intent.
In the absense of real news...which is soon coming (is that a baboon I see in the near distance?! :) )...we'll take a recap.
at Trefis dot com
Biotech Catalyst Trade In Focus: Synthetic Biologics Upcoming Multiple Sclerosis Data Catalyst submitted by Scott Matusow
Similar to how a blue-chip company might have an increase in stock price before an earnings call, small-cap developmental biotechs often increase in price before important clinical data releases, Advisory Committee Meetings (ADCOM), and U.S. Food and Drug Administration (FDA) drug approvals. However, some of these developmental biotechs can actually decrease in price based on poor company financial position (subsequently leading to cash raises), management ability, and other factors.
Synthetic Biologics (SYN) expects to present top-line data from its Trimesta/Copaxone combo Phase II multi-center clinical trial involving 164 women for the treatment of relapsing-remitting multiple sclerosis (MS) in women.
The data will be presented April 29th and April 30th at the American Academy of Neurology’s (AAN) 66th Annual Meeting in Philadelphia.
Although there is no cure for Multiple Sclerosis, several companies are working on developing treatments. Synthetic Biologics is testing Trimesta (oral estriol) in conjunction with Copaxone for its effects on Multiple Sclerosis. Estriol is a hormone released during pregnancy and has been documented to help women with autoimmune diseases, including Multiple Sclerosis. In small doses, some researchers believe that Trimesta can be used as a treatment for Multiple Sclerosis. Although Trimesta has been used in Europe and Asia for over 40 years, it is not currently approved for use in the United States. In a small trial done at the University of California at Los Angeles when only using Trimesta alone, researchers found the following:
Happy for you Shermann, but I think you're going to have 'seller's remorse'! At least you've kept some shares.
This is going to go sky high. I can feel it.
The presentation was great -- it was the best one I've heard Riley do! So many things in the pipeline, going forward. So much good news on the burner this year.
I love this: "This is the year when we get to shine."
Trimesta
SYN-004
SYN-005
SYN-007
SYN-010
And that doesn't even include acinetobacter!
Movement this year on Trimesta, pertussis, C-diff AND IBS -- AMAZING STUFF!! SYN will be double digits before we know it.
You could be absolutely correct about that. It all depends upon how many flippers are on board at that time, and how many 'sell the news' forgetting C-diff, Effirma and other indications with XON are also awaiting movement. In fact, we could have movement on any one of those or more than one of those even before results. C-diff is the biggie, particularly with the focus (via the media) and extra allocated dollars by US taxpayers (via their government). The need is there and now so are the funds. SYN is perfectly positioned to make something happen here.
Congratulations, longs! Great day for SYN! Seems poised to break $3 again this week. Results next month, if good, will send SYN to $5 ++. Dr. Voskuhl is about to get some long-deserved satisfaction for all her persistence. IMO
I agree and easily too Shermann!
Still accumulation going on, but at a higher PPS. Too much buying interest to knock it down much or for long. This will happen all the way until results are announced. Yes, we will head up, but in a controlled way -- which is fine by me. I pick up shares on dips and this gives me lots of chances to buy more.
First resistance is at $2.80, second resistance at $3. We need strength to blow through, but we will. We will do it before results are announced, IMO.
I don't consider 70s very overbought. The RSI is not as high as it can get and of course, it can run high for awhile, depending upon incentives.
PLUS, it looks like we could have the makings of another high and tight flag (early to tell, I know, but the volume and upward action is looking very good, into results).
Yes, it is like investing in two different companies! Except for two constants - Trimesta and Effirma. I initially invested on Trimesta. I liked the data, the prospects, etc. for MS. And I really thought Dr. Voskuhl a very bright and determined lady -- she has been at this for a LONG time and deserves a big hit! There are some employees there who have been around for awhile as well, like the gal in communications -- and I like them too.
Back in the AEN days, they seemed to get off track with the zinc stuff. When Kirk and his management team came on board, there was a big re-focus on cutting edge therapies (all the synthetic/beta lactamase stuff -- the don't kill it, make it work for you thinking sounded really, really good). After I did my DD on the science, I was stoked. Here I was investing in Trimesta and LOOK what I got instead! :) So, yes, been buying ever since. Kirk is no slouch when it comes to investing in biotechs. If he's in, I'm in.
Alone, Trimesta makes SYN worth north of $5. And yet there is so much more to offer investors now. At this PPS, it is such a no-brainer, IMO. Folks are just beginning to notice.
GLTU
"late to the party" -- lol
I've been here for 4 years investing in SYN! My first buy was at $.86. I've got a pretty nice long term gain going. And some nice short term gains too! By the time I cash out, they'll all be long term gains!! It'll be double digits by then. I'm particularly excited about C-diff, pertussis and the IBS stuff. I think Effirma will be good news too. That's one people tend to forget about, because we don't really control it.
My best guess on Trimesta is that it very much works in a stat sig way. I don't think you announce results at a prestigious conference if you don't have something really good to report.
By April, this could be well over $5 on Trimesta alone!
My concern is that with all the notice now, people will be fooling around with it until results. The big swings will start, when it's been steady eddy for awhile now. Great for the players, but frustrating for the longs. But as I do with other stocks that get into this mode, I'll be buying more on the dips.
GLTA
Ha, everyone wants to NOW notice SYN! Where's everyone been?!
It's been pretty lonely in here -- back since December when I was telling everyone to buy the $1 financing deal, that it would most definitely rise into results, etc. etc. Me, Funman, a few others. That's all. Looks like biochica came back. Welcome back, lady!
Who are all you new people hanging out in here anyway!!!?? It's all of a sudden the party board! :D :D
Obviously, I'm a long term holder. I've got lots of shares, most recently at $.98 when I bought the offering, but then I just had to pick up a few more in Jan ($1.48).
SYN is the best small cap bio out there with the best pipeline. Period. The best. Just now some folks are figuring it out!! Anyone who sells before SYN is well into double digits is selling themselves short and will be kicking themselves. I'm telling you all, this is one of those once-in-a-lifetime deals. IMVHO, of course. I am not a flipper here. Just a long term investor. Most of my gains are LT at this point. The charts indicate up. And the fundamentals indicate BIG UP, long term.
GLTA -- and welcome aboard!
Ann