Synthetic Biologics, Inc. (NYSEMKT:SYN)

CAPS Rating: 2 out of 5

A development-stage, specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of neurologic and fibrotic diseases.

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Member Avatar zzlangerhans (99.77) Submitted: 5/3/2014 4:56:35 PM : Outperform Start Price: $1.33 SYN Score: +62.73

I didn't have a red thumb on Synthetic Biologics ahead of the Trimesta phase II topline data because I thought the primary reason for the recent run-up in share price was the Intrexon collaboration, not the trial. I mean, how could anyone expect success from Synthetic Biologics after all their late stage trial failures and name changes? Are memories really that short?

Apparently they are. The stock is down more than 50% from recent highs after the primary endpoint of relapse rate after 24 months missed statistical significance. I just had a chance to review the PR, and honestly it's not that awful, at least compared to prior failures such as Zinthionein. Missing stat sig on a non-registrational controlled phase II trial creates a substantial gray area. The purpose of a phase II trial is to assess the value of proceeding to larger, more expensive phase III trials. A phase II trial that shows no benefit over placebo or significant toxicity will often result in discontinuation of the program, and I think Synthetic Biologics is being priced for discontinuation of the Trimesta program. However, early pronouncements from the company indicate that they do believe they have a basis for phase III trials.

Is Trimesta a viable therapeutic for multiple sclerosis based on the phase II data? The reduction in relapses at 12 months was stat sig, and the reduction at 24 months appeared impressive on the surface although stat sig was not reached. If Synthetic Biologics proceeds to phase III, will they tweak the endpoint or other aspects of the trial design? The answer depends on the FDA's criteria for approving drugs for relapsing remitting multiple sclerosis, which I do not currently have time to investigate. Is a stat sig benefit after one year good enough, or does the company have to generate stat sig topline data after 24 months? And what about cognitive function? Another phase II trial of Trimesta with this primary endpoint continues to enroll. Is a stat sig benefit in cognitive function after one year sufficient to garner approval?

Lots of questions here and not many answers, at least from me. Nevertheless, the combination of a severe haircut in share price, the likelihood of progression to phase III in this highly promotional company, and the preclinical anti-infective assets is sufficient to generate a green thumb rating. It remains to be seen if this ever turns into a trade-grade opportunity.

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Member Avatar QUINT27 (< 20) Submitted: 2/21/2014 7:15:16 AM : Outperform Start Price: $2.73 SYN Score: -25.55

Trimesta results in April will double stock value.

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Member Avatar Allstar13913 (99.82) Submitted: 7/30/2011 9:32:54 PM : Underperform Start Price: $1.80 SYN Score: +22.13

Crap Pharma. Has not been profitable in 10 years.

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Member Avatar vpdjuric (20.18) Submitted: 1/21/2011 3:02:18 AM : Outperform Start Price: $1.45 SYN Score: +0.62

I have to respectfully disagree with zz below. Zinth is definitely not a cure for Alzheimer's, and it is not advertised as such. It is a prescription medical food meant to slow cognitive degradation seen in Alzheimer's and similar diseases. The hypothesis is that since there is a significant correlation between zinc deficiency and degradation of cognitive function, taking zinc supplements may slow cognitive deterioration. Zinth is comprised of zinc and cysteine, and both components are generally regarded as safe, which reduces the number of hurdles Adeona has to overcome to get it to market. Zinth's differentiation from standard zinc supplements is its ease of digestion, whereas common zinc supplements commonly have side effects of indigestion, nausea, and heartburn. Anecdotal results have been positive so far:

http://www.crainsdetroit.com/article/20110102/SUB01/301029993/alzheimers-trial-may-win-deal-for-adeona-supplement-interests-drug-firms#

Beyond Zinth, they are also in various stages of testing 4 other drugs for drugs for multiple sclerosis, fibromyalgia, age-related macular degeneration and rheumatoid arthritis, a couple of which have blockbuster potential. The management team, led by Dr. Kuo, is stellar, and insiders own 47% of the company. Recently, they added Dr. Anand Prasad to the team, a pioneer in zinc research.

Adeona has already received term sheets for Zinth from potential pharma partners, but nothing has been announced yet. The final data from the Zinc trials will be announced in March, although a partnership may come before then. Kuo has announced that Adeona will hold an investor day on February 8th, during which he will discuss plans for Zinth. If a partnership deal has been signed, that would probably be the day he announced it...

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Member Avatar staraman (< 20) Submitted: 9/25/2010 11:36:28 AM : Outperform Start Price: $0.81 SYN Score: +104.36

AEN has formed strong support at around 80 cents. The chart looks good from here and there some catalysts coming in 2011

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Member Avatar schrld (< 20) Submitted: 10/30/2007 7:18:45 PM : Outperform Start Price: $6.12 SYN Score: -98.77

this co is incredibly overlooked. It is less than 6 months from having a drg on the market and has a full pipeline. At a cap of only 100million and a float of only 5 million! this stock could have a powerful explosion as their story unfolds and th market becomes aware of them.

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Member Avatar SPECTRE2147 (66.49) Submitted: 10/25/2007 10:17:16 AM : Outperform Start Price: $6.92 SYN Score: -104.79

GOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOD

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Member Avatar samsung2008 (< 20) Submitted: 8/18/2007 12:03:34 AM : Outperform Start Price: $6.10 SYN Score: -107.56

This stock will explode up one day, maybe several days, maybe for months...when the right news hits. News not to far away.

This stock could hold up well in down turns and I expect if Gen. Market conditions improve to the upside, PP could do very very well.

Good products in clinical testing, but market not to far away.

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Member Avatar dcuenin (< 20) Submitted: 5/25/2007 6:31:13 AM : Outperform Start Price: $4.07 SYN Score: -84.31

blabla

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