SPEX - Sector: Healthcare --- Industry: Medical Laboratories & Research

[comovaivoce]

TARGET: 10+

TYPE 2 DIABETES DRUG TO START PHASE 3 CLINICAL TRIALS SOON....

PROFITABLE....6M SHARE FLOAT...$10M CASH.....ZERO DEBT.....ONLY $30M MARKET CAP.

ON MARCH 13, 2007, SPHERIC (NASDAQ: SPEX)  WAS AWARDED A US PATENT FOR MANY HUMAN AND INDUSTRIAL APPLICATIONS FOR ITS PROPRIATORY TAGATOSE PRODUCT. THESE APPLICATIONS COULD LEAD TO BILLIONS OF DOLLARS OF YEARLY REVENUE:

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=7,189,351.PN.&OS=PN/7,189,351&RS=PN/7,189,351

On December 6 and 7, 2005 SPEX went from $1.26 to $5.85 with over 20M shares traded when it announced that the FDA had approved SPEX's diabetes 2 drug candidate Naturlose's Phase 1 and 2 clinical data:

http://stockcharts.com/charts/gallery.html?spex

Company officials expect that the first participants will begin the Phase 3 clinical trial by March/April 2007.

Regarding Phase I and Phase 2 clinical trials, the FDA agreed that:

- Naturlose has an excellent safety profile

- Naturlose taken before food consumption prevents an increase in glucose levels in the blood

- Patients taking Naturlose lost weight and experienced a significant increase in HDL or good cholesterol

Naturlose (generic name tagatose) is a naturally occurring compound found and as such it does not have the harmful side effects and existing diabetes 2 medications like Starlix, glucotrol, and insulin.

SPEX's tagatose is the newest member of the sweeteners category (potential Equal and Splenda replacement). Tagatose has been granted GRAS (Generally Recognized As Safe) status by the FDA allowing it to be included in foods as a sweetener.

On December 15, 2006, SPEX announced that tagatose was formally approved "as a novel food ingredient" by the European Union (EU) permitting the use of the sweetener in a wide range of of products from soft drinks, to candy, to tooth paste. The approval followed approval by South Korea, Australia, New Zealand, Brazil and other countries.

http://www.thestreet.com/pf/markets/marketfeatures/10257689.html

On October 27, 2006, SPEX reported that it had successfully completed its dose range-finding study, allowing it to continue with its Phase 3 clinical trial of Naturlose as a treatment for type 2 diabetes.

"The test results so far have been positive," said Spherix President Richard Levin. "Not only did they determine the dose and timing for the trial, but the results corroborate what we have seen in previous tests -- that Naturlose has a beneficial effect on modulating postprandial blood glucose, an important factor in the treatment of Type 2 diabetes.

We are moving forward with confidence that we have a scientifically sound foundation on which to complete the Phase 3 trial, and to anticipate a favorable outcome."

Levin said that the Company's recently announced a settlement whereby Spherix agreed to accept $6 million to end a longstanding legal dispute. Spherix intends to use a portion of that payment to support its efforts to develop Naturlose as a marketable product. Spherix believes these funds, along with existing cash, will ensure its ability to complete the Phase 3 clinical trial.

Unlike other biotecs, SPEX funds its BioSpherix Division's clinical development through strong earnings from its InfosPherix, information services division.

SPEX has been profitable or break-even the last 2 quarters due to InfoSpherix's strong recent increase in backlog (to $75M) and new contracts despite a huge jump in R&D expenses to fund its clinical trials.

http://finance.yahoo.com/q/is?s=SPEX


ABOUT SPEX:


Spherix Incorporated (Nasdaq: SPEX) engages in the provision of information management and services (InfosPherix Division), as well as in the biotechnological research and development of a family of drugs using the company's propriatory Naturlose/tagatose brands (BioSheprix Division).

[comovaivoce]

Friendly reminder....

SPEX will report 4Q 2006 and FY 2006 financial results by the end of the month.... or less than 8 more trading days

This is why i believe SPEX might be a big gainer:

- SPEX will likely announce the start of Phase 3  clinical trials for its Naturlose diabetes 2 drug candidate before earnings are released....or maybe after.

- There are 2 other clinical studies going on and there might be updates on those as well. One of them is the use of Naturlose as an anti-gingivitis and anti-plaque agent for use in toothpaste, mouthwash and chewing gum. The second study is the use of Naturlose as an agent to oreserve blood products to improve blood trnsfusions.

-  THIS IS HUGE.....SPEX WILL VERY LIKELY BE PROFITABLE FOR THE WHOLE YEAR FOR THE FIRST TIME THIS DECADE...

---- why??

- Because SPEX information services division InfoSpherix has been doing exeptionally well this year having lost only a cummulative $300K in the first 9 months of 2006 despite a huge increase in R&D costs to advance its Phase 3 and other biotec activities.

http://finance.yahoo.com/q/is?s=SPEX

- And because SPEX has received a $6M legal settlement in October 2006 or during 4Q. This amount will likely show up as a non-recurring income but it will boost SPEX earnings for the year I believe ito the 20c/share range, Compared this with a 20c/share loss in 2005.

OK, now what do we have here?

- A profitable biotec with a promising diabetes 2 drug entering Phase 3 clinical trials.

- A company with a huge intellectual property

- A company that discovered and owns the patents for tagatose, the newest sweetener that could eventually yake some market share from Splenda and Equal. The problem here is that SPEX has an agreement with a company that is really doing nothing to tap on the huge potential that tagatose has,

- A company with about $10M cash and no debt.

- A company that has not had dilution and it will not have it to further its biotec arm. This according to the founder/CEO Levin. Dr. Levin own over 20% of SPEX outstanding shares

- A company with a float of only 6M shares and 14M oustanding shares

A GROSSLY UNDERVALUED BIOTEC COMPANY THAT IS PROFITABLE AND HAS ENOUGH MONEY AND RESOURCES TO COMPLETE PHASE 3 CLINICAL TRIALS WITH A CURRENT MARKET CAP OF ONLY $30M !!!!!!!!

In my opinion 2 the following scenarios are likely..

- That after the stock goes over $5 it will really take off because institutions will try to grab as many of those scarce float shares as they can.

- or the company will be sold. More and more pharma companies are acquiring smaller biotecs with promising drugs to shorten the time to market and to reduce development costs.

Either way, my conservative target is $6+ by the end of 2007 and $40 in 2009

[Terliso]

Short-term long on SPEX goodluck, make some dollars!

[setravis]

comovaivoce , this message is especially for you!
You did the same thing on the prior page of this thread.


"SPEX" Threads have been Merged.
Please use the search before starting new threads on a Stock Pick.
Chances are a thread already exist.
So why not post whatever you have to comment about on that pick to that thread.
"Simplicity" My fellow traders.                                   
All history on a stock pick in 1 thread is awesome.                                 
Just trying to get threads together,so we don't have a numerous amount floating around on the same stock.             
Thank You....and good luck with all your trades....make some $$$             

[Terliso]

Chart Update.

[ravenquork]

Chart Update.

Some news today: http://xml.10kwizard.com/filing_raw.php?repo=tenk&ipage=4763188

Spherix Incorporated

$4 Million Standby Equity Distribution Agreement

Common Stock

The common stock, par value $.005 per share, being offered hereby is common stock acquired from Spherix Incorporated, a Delaware corporation (the "Company") pursuant to a draw down under the provisions of that certain Standby Equity Distribution Agreement dated as of July 22, 2005 ("Equity Line of Credit") by and between the Company and Cornell Capital Partners, L.P.  The description in this Prospectus Supplement of the particular terms of the shares of common stock offered hereby supplements (and, to the extent inconsistent, replaces) and should be read in conjunction with the description of the general terms and provisions of the common stock and the Equity Line of Credit set forth in the accompanying Prospectus, dated October 12, 2005, to which description reference is made hereby.  The price per share is based on the lowest volume weighted average price of the common stock on the NASDAQ National Market for the five (5) consecutive trading days immediately following the draw down notice date.  Terms used but not defined herein have the meanings ascribed to them in the Prospectus.

The particulars relating to the common stock offered hereby are as follows:

Purchaser:
   


   

Cornell Capital Partners, L.P.

Issue Date:
   


   

March 22, 2007

Number of shares issued:
   


   

77,632

Purchase price per share:
   


   

$1.9322

Net Proceeds to the Company:
   


   

$142,000

[comovaivoce]

REMINDER: Big week coming up for SPEX

I expect that SPEX will announce 4Q and FY 2006 financial results nect week. I expect a profitable year for the first time this decade.

I also expect an announcement about the start of Phase 3 clinical trials for SPEX diabetes 2 drug candidate Naturlose.

SPEX HIGHLIGHTS:

- SPEX WILL REPORT ITS FIRST PROFITABLE YEAR OF THE DECADE ON OR BEFORE MARCH 30, 2007

- SPEX WILL START PHASE 3 CLINICAL TRIALS OF ITS DIABETES 2 DRUG NATURLOSE. I EXPECT AN ANNOUNCEMENT AROUND EARNINGS TIME

- SPEX's MARKET CAP IS ONLY $30M!!

- SPEX WILL HAVE ABOUT $10M CASH AND NO DEBT AT THE END OF 2006

- SPEX HAS A FLOAT OF ABOUT 6M SHARES AND A TOTAL OF 14M OUTSTANDING SHARES

- SPEX HAS MANY PATENTS WITH THE MOST RECENT BEING AWARDED MARCH 13, 2007


On December 6 and 7, 2005 SPEX went from $1.26 to $5.85 with over 20M shares traded when it announced that the FDA had approved SPEX's diabetes 2 drug candidate Naturlose's Phase 1 and 2 clinical data:

http://stockcharts.com/charts/gallery.html?spex

Company officials expect that the first participants will begin the Phase 3 clinical trial by March/April 2007.

Regarding Phase I and Phase 2 clinical trials, the FDA agreed that:

- Naturlose has an excellent safety profile

- Naturlose taken before food consumption prevents an increase in glucose levels in the blood

- Patients taking Naturlose lost weight and experienced a significant increase in HDL or good cholesterol


WHY DO I THINK SPEX WILL REPORT A PROFIT FOR 2006??

1) SPEX's information services division InfoSpherix has been doing exceptionally well this year having lost only a total $300K in the first 9 months of 2006 despite a huge increase in R&D costs to advance its Phase 3 and the rest of its clinical program.

http://finance.yahoo.com/q/is?s=SPEX

2) SPEX has received $6M from a legal settlement in October 2006 or during 4Q. This amount will show as a non-recurring income and it will boost SPEX earnings for the year I believe to the 20c/share range. This compares favorably with the 20c/share loss in 2005.

SPEX CEO Levin recently stated:...." Spherix intends to use a portion of that payment to support its efforts to develop Naturlose as a marketable product. Spherix believes these funds, along with existing cash, will ensure its ability to complete the Phase 3 clinical trial..."

SPEX is a very unusual biotec in that the company that has not had to resort to dilution to fund its clinical research. CEO Levin owns over 20% of SPEX outstanding shares and is the largest SPEX shareholder.


IMO, THE BOTTOM LINE IS THIS:

SPEX IS THE ONLY PROFITABLE BIOTEC COMPANY UNDER $30M MARKET CAP HAVING ENOUGH MONEY AND RESOURCES TO COMPLETE PHASE 3 CLINICAL TRIALS (AND DOES NOT EXPECT DILUTION AS MOST BIOTECS DO).

SPEX's MARKET CAP SHOULD BE $140M+ OR $10/SHARE TO BE ON THE LOWER END OF BIOTECS HAVING A PHASE 3 DRUG FOR A MAJOR ILLNESS LIKE DIABETS 2.

In my opinion 2 the following scenarios are likely..

- That after the stock goes over $5 it will really take off because institutions will try to grab as many of those scarce float shares as they can.

- or the company will be sold. More and more pharma companies are acquiring smaller biotecs with promising drugs to shorten the time to market and to reduce development costs.


ABOUT SPEX:


Spherix Incorporated (Nasdaq: SPEX) engages in the provision of information management and services (InfosPherix Division), as well as in the biotechnological research and development of a family of drugs using the company's propriatory Naturlose/tagatose brands (BioSheprix Division).

[Terliso]

Looking better now. Up over 14%

[vivaviagra]

SPEX $1.06...PHASE 3 POTENTIAL BLOCKBUSTER SAFE DIABETES II DRUG...RESULTS IN 3 MONTHS   

CURRENT MARKET CAP $15M....$1/SH CASH...NO DEBT

Early results of its Diabetes II Phase 3 clinical trials are expected within 3 months. The company is looking for a major pharma company to partner in this potentially incredible opportunity.

SPEX with a float of 8M shares could explode once investors learn that this small company has a safe drug undergoing Phase 3 trials that not only effectively controls blood glucose levels, but it also reduces weight, and increases HDL....the good cholesterol.

The following is an abstract from a medical journal published 2 weeks ago.

Tagatose, a new antidiabetic and obesity control drug

Abstract

Under an FDA-affirmed protocol, Spherix is currently conducting a phase 3 trial to evaluate a placebo-subtracted treatment effect based on a decrease in HbA1c levels. Side effects, contraindications and possibly beneficial new findings will be carefully monitored.

It is hoped that early results of the trial may become available by mid-2008.

If a subsequent NDA is successful, tagatose may fill a major health need.

A potentially important new drug for treating type 2 diabetes, tagatose, is now in phase 3 clinical trial. The history, development, additional health benefits, mechanisms of action and the potential for the drug are presented in context with a review of the rapidly growing epidemic of type 2 diabetes and treatments for it.

An epimer of fructose, the natural hexose tagatose was originally developed by Spherix Incorporated (formerly Biospherics Inc.) as a low-calorie sugar substitute. Only 20% of orally ingested tagatose is fully metabolized, principally in the liver, following a metabolic pathway identical to that of fructose. Following a decade of studies, tagatose became generally recognized as safe for use in foods and beverages under US FDA regulation. The simple sugar is commercially produced by isomerization of galactose, which is prepared from lactose.

Early human studies suggested tagatose as a potential antidiabetic drug through its beneficial effects on postprandial hyperglycaemia and hyperinsulinaemia. A subsequent 14-month trial confirmed its potential for treating type 2 diabetes, and tagatose showed promise for inducing weight loss and raising high-density lipoprotein cholesterol, both important to the control of diabetes and constituting benefits independent of the disease. Furthermore, tagatose was shown to be an antioxidant and a prebiotic, both properties cited in the maintenance and promotion of health. No current therapies for type 2 diabetes provide these multiple health benefits.

The predominant side effects of tagatose are gastrointestinal disturbances associated with excessive consumption, generally accommodated within 1- to 2-week period. The health and use potentials for tagatose (branded Naturlose® for this use) are given with respect to current type 2 diabetes drugs and markets.


SPEX is currently trading below its $1.1/share cash....the company has no debt 

More info on Tagatose:

http://www.umm.edu/news/releases/tagatose.pdf

[bounceahead]

Keep an eye on SPEX in the next few weeks....

SPEX could increase its market cap 10 to 100-fold if its Diabetes II drug candidate is approved by the FDA.

Early results of SPEX's Diabetes II drug candidate Tagatose undergoing Phase 3 clinical trials are expected within 3 months.

Results for FDA-approved Phases 1 and 2 were very successful and encouraging. Tagatose, is a low-calorie sweetener with a remarkable safety profile. The company is looking for a major pharma company to partner in this potentially incredible opportunity.

In addition to effectively controlling glucose levels, Tagatose has been proven to be very effective in weight-control as well as been able to increase HDL....the good cholesterol.

The following is an abstract from a medical journal was published 2 weeks ago.

Tagatose, a new antidiabetic and obesity control drug

Abstract

Under an FDA-affirmed protocol, Spherix is currently conducting a phase 3 trial to evaluate a placebo-subtracted treatment effect based on a decrease in HbA1c levels. Side effects, contraindications and possibly beneficial new findings will be carefully monitored.

It is hoped that early results of the trial may become available by mid-2008.

If a subsequent NDA is successful, tagatose may fill a major health need.

A potentially important new drug for treating type 2 diabetes, tagatose, is now in phase 3 clinical trial. The history, development, additional health benefits, mechanisms of action and the potential for the drug are presented in context with a review of the rapidly growing epidemic of type 2 diabetes and treatments for it.

An epimer of fructose, the natural hexose tagatose was originally developed by Spherix Incorporated (formerly Biospherics Inc.) as a low-calorie sugar substitute. Only 20% of orally ingested tagatose is fully metabolized, principally in the liver, following a metabolic pathway identical to that of fructose. Following a decade of studies, tagatose became generally recognized as safe for use in foods and beverages under US FDA regulation. The simple sugar is commercially produced by isomerization of galactose, which is prepared from lactose.

Early human studies suggested tagatose as a potential antidiabetic drug through its beneficial effects on postprandial hyperglycaemia and hyperinsulinaemia. A subsequent 14-month trial confirmed its potential for treating type 2 diabetes, and tagatose showed promise for inducing weight loss and raising high-density lipoprotein cholesterol, both important to the control of diabetes and constituting benefits independent of the disease. Furthermore, tagatose was shown to be an antioxidant and a prebiotic, both properties cited in the maintenance and promotion of health. No current therapies for type 2 diabetes provide these multiple health benefits.

The predominant side effects of tagatose are gastrointestinal disturbances associated with excessive consumption, generally accommodated within 1- to 2-week period. The health and use potentials for tagatose (branded Naturlose® for this use) are given with respect to current type 2 diabetes drugs and markets.

By the way, Tagatose already won FDA's GRAS designation...(generally safe for human consumption)

[bounceahead]

More SPEX info for those interested in this stock:

A Clinical Study to Evaluate the Effect of Naturlose (Tagatose). This study is currently recruiting participants

http://www.clinicaltrials.gov/ct2/show/NCT00451477?term=D-tagatose&rank=1

NATURAL SUGAR CALLED TAGATOSE MAY HOLD PROMISE AS NEW DRUG TO TREAT TYPE 2 DIABETES

University of Maryland endocrinologist co-authors article outlining possible benefits

http://www.umm.edu/news/releases/tagatose.htm

Tagatose, a new antidiabetic and obesity control drug

http://www.umm.edu/news/releases/tagatose.pdf

[setravis]

updated chart look...

[iamonfire]

RECENT EXCELLENT PHASE 2 RESULTS SEND THE STOCK TO $3.....NOW IT'S RETRACED AND FORMED A BAS....11M SHARE FLOAT. PHASE 3 RESULTS EXPECTED SOON

SPEX announced excellent Phase 2 preliminary results for its Diabetes 2 drug Naturlose last week. Naturlose (D-Tagatose) is extremely safe because it has been used as an artificial sweetener for years. D-Tagatose was discovered by SPEX's founder Dr. Levin. SPEX has the patent for the pharmaceutical use of this product.

Here is the announcement that woke up this sleeper last week. The float is only 11 million shares.

http://www.medicalnewstoday.com/articles/155245.php

Phase 3 is currently underway.

http://www.fdable.com/clinical_trials/query/0bffcf864e8c

SPEX Will file a NDA application for this drug at the end of the year. Here is an excerpt of a recent announcement:

..."Spherix is currently investigating Naturlose as a treatment for Type 2 diabetes in a Phase 3 clinical trial. The company expects preliminary results from this Phase 3 study in the fall of 2009, and plans to file a New Drug Application (NDA) with the FDA shortly after the conclusion of the Phase 3 study if the results are positive..."

In addition to controlling glucose, Naturlose lowers the bad cholesterol LDL, and controls obesity.

SPEX market cap is currently less than $20M. This little biotec co. could become a 20-bagger soon.

ACCUMULATE...ACCUMULATE ...ACCUMULATE