Excerpt from YERR 10K – 2nd last paragraph is the kicker!




DECEMBER 31, 2015 AND 2014


The consolidated financial statements include the financial statements of Yangtze River Development Limited (the “Company” or “Yangtze River”) and its subsidiaries, Energetic Mind Limited (“Energetic Mind”), Ricofeliz Capital (HK) Limited (“Ricofeliz Capital”), and Wuhan Yangtze River Newport Logistics Co., Ltd. (“Wuhan Newport”).

The Company, formerly named as Kirin International Holding, Inc., and Ciglarette, Inc., was incorporated in the State of Nevada on December 23, 2009. The Company was a development stage company and has not generated significant revenue since inception to March 1, 2011.

On March 1, 2011, the Company entered into a share exchange agreement that Kirin China Holding Limited (“Kirin China”) became the Company’s wholly-owned subsidiary. Kirin China engaged in the development and sales of residential and commercial real estate properties, and development of land lots in People’s Republic of China (“China”, or the “PRC”).

On December 19, 2015, the Company completed a share exchange (the “Share Exchange”) with Energetic Mind and all the shareholders of Energetic Mind, whereby Yangtze River acquired 100% of the issued and outstanding capital stock of Energetic Mind, in exchange for 151,000,000 shares of Yangtze River’s common stock, which constituted approximately 88% of its issued and outstanding shares on a fully-diluted basis of Yangtze River immediately after the consummation of the Share Exchange, and an 8% convertible note (the “Note”) in the principal amount of $150,000,000. As a result of the Share Exchange, Energetic Mind became Yangtze River’s wholly-owned subsidiary and Jasper Lake Holdings Limited (“Jasper”), the former shareholder of Energetic Mind, became Yangtze River’s controlling stockholder. The Share Exchange transaction with Energetic Mind was treated as an acquisition, with Energetic Mind as the accounting acquirer and Yangtze River as the acquired party. The financial statements before the date of the Share Exchange are those of Energetic Mind with the results of the Company being consolidated from the date of the Share Exchange.

Energetic Mind owns 100% of Ricofeliz Capital and operates its business through its subsidiary Wuhan Newport.

Wuhan Newport was a wholly owned subsidiary of Wuhan Renhe Group Co., Ltd. (the “Wuhan Renhe”), a company incorporated in the PRC as at September 23, 2002. On July 13, 2015, Wuhan Renhe transferred all of the equity interests of the Company to Ricofeliz Capital, a company incorporated in Hong Kong on March 25, 2015. Ricofeliz Capital was incorporated by Energetic Mind, a company incorporated in British Virgin Islands (“BVI”). Energetic Mind was incorporated by Mr. Liu Xiangyao on January 2, 2015, and was subsequently purchased by various companies incorporated in BVI or the United States of America (“USA”), among whom Jasper became its 64% owner. Jasper was 100% owned by Mr. Liu Xiangyao, a Hong Kong citizen.

The major assets of Wuhan Newport include land lots for developing commercial buildings that are in line with the principal activities of Kirin China.

On December 31, 2015, the Company entered into certain stock purchase and business sale agreements (the “Agreements”) with Kirin Global Enterprises, Inc. (the “Purchaser”), a California corporation and an entity controlled by a former officer and director of the Company whereby the Company sold its interest in certain subsidiaries (see note 11) for an aggregate of $75,000,002. (the “Sale”).

Pursuant to the terms of the Agreements, Jasper agreed to finance the Sale by reducing Company’s financial obligations of the Note by an aggregate of $75,000,000. In addition, the Purchaser agreed to pay the remaining two dollar in cash.

Upon completion of the Sale, the Company operates its business solely through its subsidiary Wuhan Newport, primarily engaging in the business as a port logistic center located in the middle reaches of the Yangtze River in the PRC.


$NVAX charts & options market analysis, suggests the majority didn’t anticipate stock price below $4.00 per share.

NVAX: Novavax Announces Topline RSV F Vaccine Data from Two Clinical Trials in Older Adults

After Hours Quote: $ 1.38 -$6.96 (-83.45%) due to news.  Obviously “bad news” ….. i guess… as per the market’s reaction, but for the stock to drop 87% ?!?  I bought some shares at $1.35 in after hours market. Trading in the stock closed at $8.34 today in regular hours and closed at $1.40 after hours.

All-time data, monthly chart below. Note the 52 Week Range: $4.075 to $10.70.



Below is a 1 year daily chart where you can see the drop from $8.34 down to $1.40.  I also have plotted the option implied volatility which you can plainly see a run-up from mid July 2016 95% to current date Sept 15 where it peaked at 248%.   The higher the implied volatility, the higher the cost of the options.  I also added the option open interest which plots the call and put open interest in the $NVAX options market.

$NVAX Daily chart 09-15-2016
$NVAX Daily chart 09-15-2016

In addition, here is the historical and implied volatility from the OIC.


Today there was a total of 18,524 options that were traded before $NVAX distributed their news.  A total of 9,435 calls vs 9,089 puts making the put/call ratio a balanced 0.963.  The majority of today’s options volume came from the October expiration, and secondly the September contract.


An interesting point I will make is that it looks as if the NVAX market was not expecting the stock price to drop this far!  If you notice there is hardly any options traded below the $4 strike PUT contract, in other words nobody was interested in buying downside protection or insurance in fear of a downside move in the stock price.  I’ve outlined a red rectangle around the option strikes that had the most trading activity today to make it easier to follow.  Basically you can see that nobody thought NVAX was going to plunge the way it did today.


Below is the NVAX option time & sales showing the largest option trades that occurred today, along with the last 15 minutes of option trades before the close.


The final chart is a 3 minute chart plotting the after hours trading activity.


Retail Investor’s Favorite Stocks $SPY $AAPL $GOOG $FB $GE $BAC $MSFT

The past week or two I’ve been thinking about the idea of finding the stocks which retail investors are most heavily invested in, or followed.  This idea came from my recent ideas about trading liquid stocks and options, and finding which companies are the “people’s favourites.”  Trying to stay active in the popular and liquid names of, the people.

I found this list which is from Jun. 10, 2015.
Stocks mentioned:
Facebook (NASDAQ:FB)
General Electric (NYSE:GE)
Bank of America (NYSE:BAC)
Microsoft (NASDAQ:MSFT)
Ford (NYSE:F)
Citigroup (NYSE:C)
International Business Machines (NYSE:IBM)
Exxon Mobil (NYSE:XOM)
Johnson & Johnson (NYSE:JNJ)
Verizon (NYSE:VZ)
Pfizer (NYSE:PFE)
Gilead Sciences (NASDAQ:GILD)
Coca-Cola (NYSE:KO)
JPMorgan Chase (NYSE:JPM)
Starbucks (NASDAQ:SBUX)
Procter & Gamble (NYSE:PG)
Chevron (NYSE:CVX)
Annaly Capital Management (NYSE:NLY)
I plugged these tickers into the free finviz.com screener and saved it to my account: AAPL GOOG FB GE BAC MSFT F INTC C T CSCO TSLA AMZN IBM XOM JNJ VZ PFE GILD KO JPM SBUX PG YHOO CVX NLY

#Investment opportunity in $CLDX options market. $SPY $FB $AAPL $TSLA $AMZN $VIX #biotech #healthcare

This morning I have SOLD 10 CLDX Feb17’17 2 PUT @ 0.15 as a starter position. This is a bullish position on the company, this is a speculative "buy & hold" type of position for me.

This current market on this option contract (CLDX Feb17’17 $2.00 PUT) is 0.05 x 0.20, I offered this contract at 0.15 and got instant fill, so there is a [hidden] buyer at the $0.15 mark.

I’ve been tracking CLDX and have sold other options that have expired worthless in this name. I can currently sell CLDX put options 50% away from the current market price of $4.07 — I think this is a great deal and opportunity.

The daily chart is showing signs of an upcoming sell off, maybe even a downside breakout or gap down in the short term. There is also 21% of the float sold short. But I like the long term chart on this (weekly/monthly) as well as the fundamental value coming in at Book/sh: $2.38
Cash/sh $2.24.

All-time data weekly chart, 52wk low is $2.96

Here is what the historical and implied volatility looks like for CLDX.

CLDX Feb2017 option chain:

Most active options for CLDX as of Aug 19 2016 at 10:16 AM EST

$GLLK #penny #stock promotion – pump and dump?

GLLK Gold Lakes Corp. (Formerly=Siga Resources, Inc. until 8-2015) says, identifies itself as a company in the exploration stage, which has not generated any revenue and has no prospects of generating any revenue in the foreseeable future 
(see "Trends" in latest 10-Q). A good place to start your research is the company profile on OTCmarkets.com Here I find a quick overview of interesting items such as what the company was formerly (Formerly=Siga Resources, Inc.) and also recent stock splits, authorized shares, outstanding shares, float, etc. 
Then I google "Siga Resources, Inc" and try to find other articles or even previous stock charts of the company to get an idea or history of what the company was before, compared to what it is doing now. It also provides insight if the company is a repeat offender in the penny stock promotion and manipulation pump and dump field.  This company certainly has a well documented history, which will have a very negative effect to long term shareholders.  This article from Sept 21 2013 which states "Siga Resources Inc (SGAE) pump-and-dump spam" is rather interesting!
SGAE-formerly-GLLKIf you look at the GLLK stock chart, it appears to be a classic penny stock promotion, aka "pump and dump."  If you google Siga Resources Inc (OTC:SGAE) you will come across an article from Sept 2011 which also identified this company for running a stock promotion. hotstocked.com also wrote a new article about GLLK on July 1, 2016.

GLLK-1-year-daily-stock-chart-07-19-2016Another value investor on investorshub (iHub) said this on July 15, 2016: GLLK is Hyper Overvalued and Hyper Overbought now! It only worth $0.0005 per share at most! Sell ASAP before it crashes like its peer did... 

Below are some items that I pay attention to when reviewing quarterly financial statements. The company's latest 10-Q, received June 17, 2016 for the period ending April 30, 2016.

Total Assets: $128,456
Total Liabilities: $1,128,772
Total Stockholders' Deficiency $(1,000,316)
Revenues: ZERO
Expenses: ZERO
- It appears as though this company has no operations or ways to create money or value for it's shareholders.

Common stock 500,000,000 shares authorized, at $0.001 par value; 33,135,645 shares issued and outstanding as of April 30, 2016 (July 31, 2015 – 225,645 shares) !!!!!!!!!

The company only had 225,645 shares outstanding at July 31, 2015. And now they have 33.1 Million shares outstanding (which is actually 99 Million shares now since after the 3:1 reverse split on July 15, 2016). This appears to be major dilution to the $GLLK shareholders.

The company pays for services, debt, and property by using common shares, which also further removes real value from it's shareholders.
Shares issued for services $ 280,000
Shares issued for debt $ 4,400,000
Shares issued for property $ 23,500,000

If you read through the company's latest 10-Q,another good search to see the quality of the company is the key word of "convertible."  This will show you how the company likes to operate.  There are 39 mentions of the word convertible in this 10-Q.  Convertibles are very hazardous to a company's financial health.  If you look at LEXG and BTCS you will see what the effects of convertibles due to a stock chart and the value of the stock price.  It essentially sends the stock to zero in a hurry!

GLLK-10Q-convertibleBTCS-daily-chart-07-19-2016-dilutionLEXG-daily-chart-07-19-2016-dilutionBelow are quotes from the latest 10Q that make reference to "convertibles."

On November 20, 2015, the Company issued a $30,000 convertible promissory note. The note has an 8% per annum interest rate and a maturity date of November20, 2016. Closing costs of $3,500 are being amortized over the life of the loan. The note is convertible into shares of common stock of the Company at any time at a rate of 50% of the lowest trading price of the shares over the previous 20-day trading period. A conversion benefit of $30,000 has been recorded and is being
amortized over the life of the loan. A derivative liability has been calculated using Black Sholes and is estimated to be $52,276 at April 30, 2016.

On December 21, 2015, the Company issued a $50,000 convertible promissory note. The note has an 8% per annum interest rate and a maturity date of December
21, 2017. Closing costs of $5,000 are being amortized over the life of the loan. The note is convertible into shares of common stock of the Company at any time at
a rate of 50% of the lowest trading price of the shares over the previous 20-day trading period. A conversion benefit of $50,000 has been recorded and is being
amortized over the life of the loan. A derivative liability has been calculated using Black Sholes and is estimated to be $100,208 at April 30, 2016.

On December 21, 2015, the Company issued a $50,000 convertible promissory note. The note has an 8% per annum interest rate and a maturity date of December
21, 2017. Closing costs of $5,000 are being amortized over the life of the loan. The note is convertible into shares of common stock of the Company at any time at
a rate of 50% of the lowest trading price of the shares over the previous 20-day trading period. A conversion benefit of $50,000 has been recorded and is being
amortized over the life of the loan. A derivative liability has been calculated using Black Sholes and is estimated to be $100,207 at April 30, 2016.

On January 22, 2016, the Company issued a $35,500 convertible promissory note. The note has an 12% per annum interest rate and a maturity date of January 22,
2017. Closing costs of $9,050 are being amortized over the life of the loan. The note is convertible into shares of common stock of the Company at any time at a
rate of 50% of the lowest trading price of the shares over the previous 20-day trading period. A conversion benefit of $35,500 has been recorded and is being
amortized over the life of the loan. A derivative liability has been calculated using Black Sholes and is estimated to be $61,860 at April 30, 2016.

On February 25, 2016, the Company issued a $27,500 convertible promissory note. The note has an 8% per annum interest rate and a maturity date of February 25,
2017. Closing costs of $9,050 are being amortized over the life of the loan. The note is convertible into shares of common stock of the Company at any time at a
rate of 50% of the lowest trading price of the shares over the previous 20-day trading period. A conversion benefit of $27,500 has been recorded and is being
amortized over the life of the loan. A derivative liability has been calculated using Black Sholes and is estimated to be $50,583 at April 30, 2016.
On March 14, 2016, the Company issued a $285,000 convertible promissory note. The note has an 8% per annum interest rate and a maturity date of March 11,
2017. Closing costs of $35,000 are being amortized over the life of the loan. The note is convertible into shares of common stock of the Company at any time at a
rate of 50% of the lowest trading price of the shares over the previous 20-day trading period. A conversion benefit of $285,000 has been recorded and is being
amortized over the life of the loan. A derivative liability has been calculated using Black Sholes and is estimated to be $496,620 at April 30, 2016.

During the period, the Company has paid its officer consulting fees of $26,000 (2015 - $nil) and rent of $4,500 (2015 - $nil). On October 15, 2015, the Company
remunerated the officer of the Company 400,000 shares of the Company's common stock. The price of the stock was $0.43 and a charge of $172,000 has been
expensed as Shares for Service.
On November 1, 2015, there was 200,000 shares issued to a consultant. At the issue date, the fair market value of the shares was $0.50 and a charge of $100,000
has been expensed as Shares for Service.
On April 1, 2016, there was 10,000 shares issued to a consultant for services. At the issue date, the fair market value of the shares was $0.80 and a charge of $8,000
has been expensed.
The Company has received $17,500 under a promissory note agreement with a third party in July 2012. An additional $4,000 was received under this Note in 2014.
Interest and principal were due on September 15, 2012. The Company is currently in default on this Note. Per the note agreement, interest of $11,768 was accrued
through April 30, 2016 and has been disclosed on the balance sheets as accounts payable and accrued interest.
9. GOING CONCERN The Company will need additional working capital to service its debt and to develop the mineral claims acquired, which raises substantial doubt about its ability to
continue as a going concern. Continuation of the Company as a going concern is dependent upon obtaining additional working capital and the management of the
Company has developed a strategy, which it believes will accomplish this objective through additional equity funding, and long term financing, which will enable
the Company to operate for the coming year.

Corporate Organization and History within the Last Three years
We were incorporated under the laws of the State of Nevada on January 18, 2007 under the name Siga Resources Inc. We do not have any subsidiaries or affiliated
companies. Since our default have defaulted on payments to keep the ownership in the Lucky Thirteen Claim intact. Consequently, we have lost our interest in the
Lucky Thirteen Claim entirely.
We have not been involved in any bankruptcy, receivership or similar proceedings since inception nor have we been party to a reclassification, merger,
consolidation, or purchase or sale of a significant amount of assets not in the ordinary course of business. We have no intention of entering into a corporate merger
or acquisition.
Business Development since Inception
There is no historical financial information about us upon which to base an evaluation of our performance as an exploration corporation. We are a pre-exploration
stage company and have not generated any revenues from our exploration activities. Further, we have not generated any revenues since our formation on January
18, 2007. We cannot guarantee we will be successful in our exploration activities. Our business is subject to risks inherent in the establishment of a new business
enterprise, including limited capital resources, possible delays in the exploration of our properties, and possible cost overruns due to price and cost increases in
To become profitable and competitive, we commence our exploration of the Big Monty Claims or resurrect our ownership interest in the Lucky Thirteen Claim by
making the requisite payments; or we must find an alternate mining claim. We must obtain equity or debt financing to provide the capital required implement our
phased exploration program.We have no assurance that financing will be available to us on acceptable terms. If financing is not available on satisfactory terms, we
will be unable to commence, continue, develop or expand our exploration activities. Even if available, equity financing could result in additional dilution to existing
Our auditors have issued a going concern opinion. This means that our auditors believe there is substantial doubt that we can continue as an on-going business for
the next twelve months unless we obtain additional capital to pay our bills. This is because we have not generated any revenues and no revenues are anticipated
until we begin removing and selling minerals. Accordingly, we must raise cash from other sources. Our only other source for cash at this time is investments by
others in the Company.
To meet our need for cash we must raise additional capital. We will attempt to raise additional money through a private placement, public offering or through loans.
We have discussed this matter with our officers and directors. However, our officers and directors are unwilling to make any commitments to loan us any money at
this time. At the present time, we have not made any arrangements to raise additional cash. We require additional cash to continue operations. Such operations
could take many years of exploration and would require expenditure of very substantial amounts of money, money we do not presently have and may never be able
to raise. If we cannot raise it we will have to abandon our planned exploration activities and go out of business.
We estimate we will require $170,535 in cash over the next twelve months. For a detailed breakdown refer to "Liquidity and Capital Reserves". In addition, cash
will be required to cover the phase one cost of completing the exploration work for the Big Monty Claims during that period is estimated at $67,500; and, if
required the phase two costs estimated at $186,000.

$UAPC low float sub penny stock with potential breakout chart setup and NO DILUTION #oil #gas #petroleum



1- 321M OS
2- 200M float
5- $650K REVS




UAPC (United American Petroleum Corp) is a 100% real revenue producing company and a SEC audited filer with and OS of 321,867,909 shares with an AS of 750M. Float is around 250M minus the insider restricted shares. UAPC has NOT diluted even 1 share in almost two years if you go back and check all the 10k’s. Additionally, and more importantly, there are NO convertible notes whatsoever in the company’s 10k’s anymore. The importance of this is that there are NO forces of diluting MM’s working against the trading public.

NEW FILING – AMMENDENT 10 K/S: http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=10817138

Above is the certified, documented highly credible SEC filed listing on OIL RESERVES: (*Click on link and scroll down to you see the 3rd party certified SEC filed document.

As of Jan 1, 2015, we estimate the UAPC net proved reserves to be about 118,660 barrels of oil. Projected future cash shows a discounted net present value of $2,025,090. (*see the document on the page 5 or click on the link above.)

Lets do some Math:
Current Market Value of UAPC is the following on the close of market Friday, Sept. 4.
UAPC Security Details Share Structure 321,867,909 x .0011 = $354,055 a/o Sept 4, 2015
In our opinion, the company is severely UNDERVALUED based on proven documented 3rd party Oil Reserves alone. The company is revenue generating and improving rapidly in its operating losses dramatically over the last few quarters and approaching profitability. THIS COMPANY HAS OVER $2M in SEC certified and documented OIL RESERVES and has a current market value of only $354K. The FAIR MARKET VALUE at the very least if nothing else is being negotiated or being made public in more well/lease acquistions should be at least approximately .01 the very least based just on oil reserves.

Revenue: Last 6 months: (from the 10k)

Results of operations for the six months ended June 30, 2015, as compared to the six months ended June 30, 2014

Revenues . We had total revenues of $291,802 for the six months ended June 30, 2015 which were generated from oil and gas sales of $286,702 and well operating revenues of $5,100. This was a $18,580 or 6% decrease from total revenues of $310,382 for the six months ended June 30, 2014, which were generated from oil and gas sales of $305,282 and well operation revenues of $5,100. Barrels of oil per day produced (BOPD) increased to an average of 42.85 BOPD from 19.29 BOPD for the six months ended June 30, 2014.

Net Loss. For the six months ended June 30, 2015, our net loss was $180,650 as compared to a net loss of $459,597 for the six months ended June 30, 2014, an improvement of $278,947 or 61% from the prior period.-APPROACHING PROFITABILITY

Cash on Hand: $189,208 Total Cash & Receivables: $223, 207

Discussion: UAPC hit a high almost .005 back in late May on relatively light volume and for the most part declined on small volume as well mainly due to traders moving money to more active stocks in the summer duldrums and perhaps the decline of oil prices may have been a detriment as well. However, oil prices have bottomed out and are beginning to rise again as most analysts agree bottom is in there and should see prices moving back up. See- chart for crude oil prices: http://www.dailyfx.com/crude-oil
Here is the most important fact that everyone needs to realize. I scrubbed every filing back for the last few years in UAPC. The pps
back in 2013 as you can see on the chart was over .12. The reason for the decline in the pps was the conversion of several convertible notes that the company used to pay off some long term debt. It severely hurt the stock price, but I guess it’s a necessary evil if you have no cash to develop your business plan. However, as you can see now this company is growing nicely and has about $200K CASH in the bank and $2M in proven oil reserves now, but the market has overlooked that. Convertible debt kills the stock price of a company, but it also hides the true value of it until its realized my the market. That is what needs to happen with UAPC and imo it will. The decline of oil prices has not helped here over the last few months, but that is on the upswing as well.

Finally, if you look at where their oil/gas well and leases are you can see they are right in the middle of where the big
boys are playing. Here is picture of it. Notice the names of the big oil and gas companies.

Key Operations Facts

• 17 Projects (Producing)
• Almost 5,000 Acres
• 10 Counties
• 60 Wellbores

United is presently providing operational services for numerous oil and gas leaseholders in 10 Counties Statewide, covering almost 5,000 acres, containing 60 existing wellbores with many offset drilling locations identified. Including Lavaca, Frio, Gonzales, Caldwell, Jackson, La Salle, Pecos, Bastrop, Erath, Parker, Shackelford, Pecos, Lockhart, Duval, Medina, Wilbarger, Navarro, Archer and Victoria counties. We are exploring opportunities to increase both the size and locations of our operations portfolio.With our years of experience in the region, we pride ourselves on our ability to perform any duty needed in the oil field, including, but not limited to:

• Landman
• Title and leasing
• Lease work
• Pumping and gauging
• Geology and geophysics
• Reserve estimates
• Overseeing work-overs
• Re-entries and drilling
• We can also perform enhanced recovery such as water floods and gas injection and a wide array of other industry specific tasks.
Major Players in the Texas Eagle Ford Shale Field


Click link below… how any penny stocks ever list here…hardly any shows how credible this company is.

Standard & Poor’s Market Access Profile




Key Project Facts
8 Projects (Producing)
2,850 +/- Acres
8 Counties
151 wellbores

United procures assets in one the nation’s foremost energy producing states – Texas.

Producing and operating amongst industry giants such as EOG Resources (Mkt Cap 28.11B*), Devon Energy (Mkt Cap 25.92B*), Noble Energy (Mkt Cap 17.78B*), Cheasapeake (Mkt Cap 14.38B*) and Cabot Oil and Gas (Mkt Cap 6.69B*) UAPC is ideally positioned for rapid organic expansion.

United has 8 main projects, but also owns interests in many other projects.

Our operating division performs outsourced oil and gas services to other oil and gas companies. With our portfolio of well operations, we believe we have a secure, reliable source of income providing a stable base on which to build.

Please click on the links to the left to read about our specific projects.

Source: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=116821363


Additional iHub links I used as part of my DD on UAPC:



















How I used #stock #options to #invest in $TNXP #Healthcare #DrugManufacturers $SPY $FB

TNXP stock price is up 20% after reporting Positive Topline Results from Phase 2 At Ease Study of TNX-102 SL in Post-Traumatic Stress Disorder (PTSD)

On May 05 2016, I had sold a contract of the TNXP Sep16’16 2.5 PUT @ $0.85

I thought TNXP looked like a good value at these basement prices. And then I further reduced my potential cost basis price by using the vehicle of selling put options.

Here is the daily chart:

Here is the way the historical and implied volatility looked in TNXP before the news came out today:

Here is a copy of the news article from today:

May 19, 2016 – 6:01 AM EDT
TNXP $3.425 +0.525

Tonix Pharmaceuticals Reports Positive Topline Results from Phase 2 AtEase Study of TNX-102 SL in Post-Traumatic Stress Disorder (PTSD)
Conference Call and Webcast Today at 8:00 a.m. ET
Successfully-executed Dose-finding Study Identified 5.6 mg as the Efficacious and Well-tolerated Dose for Registration Studies
Plan to Meet with the U.S. Food and Drug Administration (FDA) to Finalize Phase 3 Clinical Program
Topline Data will be Presented at the American Society of Clinical Psychopharmacology Annual Meeting in Scottsdale, Arizona on May 31, 2016
NEW YORK, May 19, 2016 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix), which is developing next-generation medicines for fibromyalgia and post-traumatic stress disorder (PTSD), today announced topline results of the Phase 2 dose-finding clinical study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in military-related PTSD (AtEase Study).

The goal of the AtEase Study was to evaluate the potential clinical benefit of using TNX-102 SL to treat military-related PTSD at a dose of 2.8 mg or 5.6 mg. In a randomized, placebo-controlled study of 231 patients with PTSD at 25 U.S. clinical sites, a bedtime sublingual dose of 2.8 mg TNX-102 SL (n=90) or 5.6 mg TNX-102 SL (n=49) was compared to placebo (n=92) for the treatment of military-related PTSD. The retention rate was higher than typical for a PTSD clinical trial, since 73% completed the study on placebo, 79% on TNX-102 SL 2.8 mg and 84% on TNX-102 SL 5.6 mg. The primary efficacy endpoint was the 12-week mean change from baseline in the severity of PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) between those treated with TNX-102 SL and those receiving placebo. The CAPS-5 is a standardized structured clinical interview and serves as the gold standard in research for measuring the symptom severity of PTSD.

This dose-finding study was designed to evaluate whether a 2.8 mg dose would be an efficacious dose and to provide an opportunity for this study to be one of the pivotal efficacy studies. Although the 2.8 mg dose trended in the direction of a therapeutic effect, it did not reach statistical significance on the primary endpoint. In contrast, the 5.6 mg dose had a therapeutic effect as assessed by the CAPS-5, which was statistically significant by analysis of covariance (ANCOVA) (p-value = 0.038), even though this arm of the study was designed to include half the number of patients of the 2.8 mg arm. The AtEase Study successfully demonstrated a dose-response relationship on multiple efficacy and safety measurements. TNX-102 SL 2.8 mg and 5.6 mg were well tolerated as evidenced by the high overall completion rate in the active treatment groups, which exceeded the completion rate in the placebo group. The three treatment arms were well balanced on demographic characteristics.

There were four distinct serious adverse events (SAEs); three were in the placebo group, and one (proctitis/peri-rectal abscess), in the TNX-102 SL group, was reported to be unrelated to TNX-102 SL.

Seth Lederman, M.D., president and chief executive officer of Tonix, stated, “TNX-102 SL 5.6 mg taken sublingually at bedtime demonstrated efficacy (reduction in CAPS-5 score) and safety for the treatment of military-related PTSD compared to placebo. We are pleased to have established a dose-response relationship of TNX-102 SL in this Phase 2 PTSD study and identified the 5.6 mg dose as appropriate for Phase 3 development. We plan to meet with the FDA to discuss the clinical program to support the registration of TNX-102 SL 5.6 mg for the treatment of PTSD.”

Jonathan R.T. Davidson, M.D., emeritus professor in the Department of Psychiatry and Behavioral Sciences at Duke University Medical Center and former Director of the Anxiety and Traumatic Stress Program, and consultant to Tonix, commented, “There is a continuing need to develop effective and well-tolerated treatments for people whose daily living is impaired by PTSD. I am encouraged by the results that have emerged from this well-designed and carefully executed study and look forward to seeing this drug treatment advance into a registration clinical program.”

Dr. Lederman added, “In the last decade, there has been little activity in the recruitment of military-related PTSD patients to participate in industry-sponsored, large-scale randomized controlled clinical studies of experimental medicines. We were successful in recruiting a relevant patient population. The AtEase Study evaluated the dose-response relationship of TNX-102 SL and identified the 5.6 mg dose as a clinically effective and well-tolerated dose for registration studies. The results of the AtEase Study not only support the development of TNX-102 SL 5.6 mg towards commercialization, but also help to better understand PTSD, a serious and disabling condition affecting many veterans who have served our country. We are grateful to the participants and their families for supporting this study.”

Summaries of the preliminary efficacy and safety results are provided in the following tables:

Table 1. Preliminary Efficacy of TNX-102 SL in the AtEase Study

Assessment Domain Analysis p Values
2.8 mg
(N=90) 5.6 mg
CAPS-5 Total MMRM1 with Multiple Imputation 0.211 0.031*
Total ANCOVA 0.090 0.038*
Arousal and Reactivity MMRM 0.141 0.048*
Sleep E6 Item MMRM 0.185 0.010*
Startle E4 Item MMRM 0.336 0.015*
CGI-I2 Responder 0.240 0.041*
PGIC3 MMRM 0.075 0.035*
Sheehan Disability Scale Total MMRM 0.174 0.079
Work/school Item MMRM 0.123 0.050*
Social/leisure Item MMRM 0.198 0.031*
Family life/home responsibilities Item MMRM 0.375 0.524
1MMRM = Mixed Model Repeated Measures
2CGI-I = Clinician Global Impression-Improvement
3PGIC = Patient Global Impression of Change
*p < 0.05

Table 2. Preliminary Adverse Events Reported in > 5% of Subjects in Any Treatment Arm

TNX-102 SL
Placebo 2.8 mg 5.6 mg Total TNX-102 SL
(N=94) (N=93) (N=50) (N=143)
Local Administration Site Conditions
Hypoaesthesia oral 2 (2.1%) 36 (38.7%) 18 (36.0%) 54 (37.8%)
Paraesthesia oral 3 (3.2%) 15 (16.1%) 2 (4.0%) 17 (11.9%)
Glossodynia 1 (1.1%) 3 (3.2%) 3 (6.0%) 6 (4.2%)
Systemic Adverse Events
Somnolence 6 (6.4%) 11 (11.8%) 8 (16.0%) 19 (13.3%)
Dry mouth 10 (10.6%) 4 (4.3%) 8 (16.0%) 12 (8.4%)
Headache 4 (4.3%) 5 (5.4%) 6 (12.0%) 11 (7.7%)
Insomnia 8 (8.5%) 7 (7.5%) 3 (6.0%) 10 (7.0%)
Sedation 1 (1.1%) 2 (2.2%) 6 (12.0%) 8 (5.6%)
Upper respiratory infection 5 (5.3%) 3 (3.2%) 2 (4.0%) 5 (3.5%)
Abnormal dreams 5 (5.3%) 1 (1.1%) 1 (2.0%) 2 (1.4%)
Weight increased 5 (5.3%) 1 (1.1%) 1 (2.0%) 2 (1.4%)

Tonix’s chief medical officer, Gregory Sullivan, M.D., will present topline data from the AtEase Study at the American Society of Clinical Psychopharmacology Annual Meeting to be held in Scottsdale, Arizona on May 31, 2016.

TNX-102 SL is an Investigational New Drug and has not been approved for any indication.

Conference Call and Webcast Information

Tonix will host a conference call today at 8:00 a.m. ET to review the topline results from the Phase 2 study of TNX-102 SL. To participate in the call, please dial +1 (877) 481-7178 (domestic) or +1 (929) 387-3796 (international) and reference the access code 2193496. A replay of the conference call may be accessed through June 18, 2016 by dialing +1 (855) 859-2056 (domestic) or +1 (404) 537-3406 (international) and by using the access code 2193496. The conference call also will be webcast live on the Investors section of Tonix’s website, www.tonixpharma.com, and will be archived until June 18, 2016.

About Post-Traumatic Stress Disorder

PTSD can develop from witnessing or experiencing a traumatic event or ordeal in which there was the severe threat of or actual occurrence of grave physical harm. PTSD affects approximately 8.4 million Americans and is a chronic and severely debilitating condition in which patients re-experience the horrific traumas that resulted in the condition in the forms of intrusive memories, flashbacks, and nightmares. PTSD is characterized by disrupted sleep, anxiety, agitation, avoidance, emotional numbness and estrangement from family and friends, guilt or negative beliefs about self, and sometimes associated with clinical depression and suicidal thinking. Individuals who suffer from PTSD usually have significant impairment in social functioning, occupational disability, and an overall poor quality of life. PTSD is sometimes associated with substance abuse and unpredictable violent or suicidal behaviors. It is estimated that 20 percent of the over 2.5 million US military personnel returning from tours of duty in the recent conflicts in Iraq and Afghanistan suffer from PTSD1.

1Source: Report on VA Facility Specific Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans Diagnosed with Potential or Provisional PTSD. Cumulative from 1st Qtr FY 2002 through 1st Qtr FY 2014.

About TNX-102 SL

TNX-102 SL is designed to deliver cyclobenzaprine to the bloodstream rapidly via sublingual (under the tongue) absorption and to bypass first-pass hepatic metabolism. As a multifunctional agent with antagonist activities at the serotonin-2A, alpha-1 adrenergic, and histamine H1 receptors, TNX-102 SL is under clinical development for the treatment of PTSD and is intended to provide broad spectrum improvement by targeting sleep and the stress response. Tonix is developing TNX-102 SL 2.8 mg for daily bedtime administration for the treatment of fibromyalgia and TNX-102 SL 5.6 mg for daily bedtime administration for the treatment of PTSD.

About Tonix Pharmaceuticals Holding Corp.

Tonix is developing next-generation medicines for common disorders of the central nervous system, including fibromyalgia and PTSD. These disorders are characterized by chronic disability, inadequate treatment options, high utilization of healthcare services, and significant economic burden. This press release and further information about Tonix can be found at www.tonixpharma.com.

Safe Harbor / Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our possible need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission (the “SEC”) on March 3, 2016, and future periodic reports filed with the SEC on or after the date hereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.


Bradley J. Saenger
Chief Financial Officer
(212) 980-9155 x107

Jenene Thomas Communications (investors)
Jenene Thomas
(908) 938-1475

Dian Griesel Int’l. (media)
Susan Forman / Laura Radocaj
(212) 825-3210

Source: GlobeNewswire (May 19, 2016 – 6:01 AM EDT)

News by QuoteMedia

Time & Sales $MCC – Lots of cross trading between TD 007 & Anonymous 001.Magor Corporation (MCC:CA) 05-04-2016

Time & Sales REALTIME
Price Size Mkt Time Buy Sell
0.075 20,000 TSXV 15:31:04 001 001
0.075 50,000 TSXV 15:30:58 001 007
0.07 11,000 TSXV 14:13:21 079 001
0.07 4,000 TSXV 14:13:21 079 001
0.07 11,000 TSXV 14:09:26 007 001
0.07 5,000 TSXV 14:09:26 007 001
w 0.07 8,000 TSXV 14:09:26 007 007
w 0.07 10,000 TSXV 14:09:26 007 007
0.065 3,000 TSXV 13:54:53 001 001
0.065 20,000 TSXV 13:54:40 007 001
0.065 30,000 TSXV 13:54:40 007 001
0.065 5,000 TSXV 13:54:40 007 001
0.065 40,000 TSXV 13:06:45 007 001
0.06 20,000 TSXV 12:23:01 001 007
0.06 20,000 TSXV 12:23:01 001 007
0.06 12,000 TSXV 12:23:01 001 007
0.06 10,000 TSXV 12:23:01 001 007
0.06 5,000 TSXV 12:23:01 001 007
w 0.06 39,000 TSXV 12:23:00 007 007
w 0.06 11,000 TSXV 12:16:20 007 001
w 0.06 10,000 TSXV 12:16:20 002 001
w 0.06 6,000 TSXV 12:16:20 007 001
w 0.06 10,000 TSXV 12:16:20 007 001
w 0.06 15,000 TSXV 12:16:20 002 001
w 0.065 5,000 TSXV 12:16:20 001 001
w 0.065 15,000 TSXV 12:16:20 001 001
0.065 2,000 TSXV 10:37:46 007 079
0.07 10,000 TSXV 09:51:09 001 009
0.07 10,000 TSXV 09:51:09 001 009
0.07 5,000 TSXV 05/03 001 001
0.075 4,000 TSXV 05/03 002 001
0.075 10,000 TSXV 05/03 002 007
0.07 10,000 TSXV 05/03 001 007
0.07 4,000 TSXV 05/03 001 001
0.07 4,000 TSXV 05/03 001 007
0.07 5,000 TSXV 05/03 001 007
w 0.07 10,000 TSXV 05/03 007 007
w 0.07 16,000 TSXV 05/03 007 007