Dallas Tx 12/9/2009 9:52:28 AM
News / Business

DNNC, LJPC, SNSS, JYHW, BTIM, MESA OTCPicks.com Stocks to Watch for Wednesday, December 9th

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Our Stocks to Watch tomorrow include Donini Inc. (OTC: DNNC), La Jolla Pharmaceutical Co. (Nasdaq: LJPC), Sunesis Pharmaceuticals Inc. (Nasdaq: SNSS), JayHawk Energy Inc. (OTCBB: JYHW), BioTime Inc. (NYSE Amex: BTIM) and Mesa Air Group Inc. (Nasdaq: MESA).

 

DONINI INCORPORATED (OTC: DNNC)

"Up 128.57% on Tuesday"

 

Detailed Quote: http://www.otcpicks.com/quotes/DNNC.php

 

Donini, Inc., a New Jersey Corporation, was established in 2001 when the company acquired control by way of a reverse merger of Pizza Donini, a Canadian company that has been operating and licensing Italian style restaurants specializing in pizza and related products within the Greater Montreal Area in the province of Quebec for over 20 years. The Company has recently completed a consolidation of its operations by establishing two Canadian Subsidiaries, Donini Group Inc. and Pizzacorp DTC Franchises Inc., whose purposes are, respectively, to hold and control the intellectual property of the Company and to license the trademarks and oversee the licensed franchisees of the marks. The Company plans to expand its operations into the United States and the rest of Canada.

 

DNNC News:

 

October 15 - Donini Announces First Quarter Financial Results

 

Peter Deros, President and CEO of Donini, Inc. (OTC: DNNC), announced that the Company has filed today its Quarterly Report, which includes the Company's first quarter financial results for the period ending August 31, 2009.

 

Mr. Deros stated that while sales were less than the previous period, the operating expenses were reduced substantially, resulting in record results. The quarterly losses for the period ($4,617) were the lowest in the Company's recent history despite the weak economic conditions in the Montreal market. Donini continues to experience good acceptance for its Pizza despite the influx of new Pizza outlets in this area over the last two years.

 

Mr. Deros stated that he is extremely optimistic about the future of the Company which is already seeing signs of improvement in cost controls under the leadership of Mr. Jean Vassiliadis, the new President of the Company's Canadian Operating Subsidiary. Mr. Deros also added that he is confident the plans for expansion and growth over the next year will be achieved under Mr. Vassiliadis's leadership. He has begun to affect changes, as in September, the Company's arrangements with three franchisees were terminated with the anticipation that new, better locations and improved management will be part of the building blocks of Donini's future.

 

LA JOLLA PHARMACEUTICAL COMPANY (NASDAQ: LJPC)

"Up 84.62% on Tuesday"

 

Detailed Quote: http://www.otcpicks.com/quotes/LJPC.php

 

La Jolla Pharmaceutical Company is dedicated to improving and preserving human life by developing innovative pharmaceutical products. The Company's leading product in development is Riquent®, which is designed to treat lupus renal disease by preventing or delaying renal flares. Lupus renal disease is a leading cause of sickness and death in patients with lupus. The Company has also developed potential small molecule drug candidates to treat various other autoimmune and inflammatory conditions.

 

LJPC News:

 

December 8 - Emerging Stock Report Initiates Independent Research Coverage on La Jolla Pharmaceutical Company

 

Emerging Stock Report, a leading provider of sector specific independent investment research, has initiated coverage on La Jolla Pharmaceutical Company (Nasdaq: LJPC). Emerging Stock Report is currently offering a complimentary trial subscription to the investment community. To view the report in its entirety visit www.emergingstockreport.com.

 

December 7 - Adamis Pharmaceuticals Announces Signing of Definitive Merger Agreement

 

Adamis Pharmaceuticals Corporation (OTCBB: ADMP), announced that it has entered into a definitive merger agreement providing for the acquisition of La Jolla Pharmaceutical Company (Nasdaq: LJPC) by Adamis. The transaction was unanimously approved by the boards of directors of both companies and is anticipated to close by the end of the first calendar quarter of 2010 or as soon thereafter as possible. Completion of the transaction is subject to a number of customary closing conditions, including the effectiveness of a registration statement to be filed with the Securities and Exchange Commission relating to the transaction, and approval of Adamis’ and La Jolla’s respective stockholders at stockholder meetings following distribution of a definitive joint proxy statement. After completion of the merger, the combined company expects to trade under the name “Adamis Pharmaceuticals Corporation”.

 

Adamis’ chief executive officer, Dr. Dennis J. Carlo, will become the chief executive officer of the combined company. Dr. Carlo is a veteran of the pharmaceutical and biotechnology industry. He previously served as CEO of publicly-traded Immune Response Corporation, Vice President of Research and Development and Therapeutic manufacturing of Hybritech Inc. prior to its acquisition by Eli Lilly & Co., and Director of Bacterial Vaccines and Immunology at Merck & Company. Dr. Carlo stated, “This merger is a strategic move to raise additional capital for the purpose of increasing the marketing and sales efforts of our Epinephrine Injection USP 1:1000 (0.3mg Pre-Filled Single Dose Syringe) product that we recently launched. In addition, we believe that La Jolla has over ten thousand stockholders and we look forward to them joining the Adamis stockholder base.” Based on its most recent quarterly report filed with the Securities and Exchange Commission, at September 30, 2009, La Jolla had cash and cash equivalents of approximately $5.8 million and liabilities of approximately $1.0 million. La Jolla anticipates that there will be $2.5 million to $3.0 million net cash left in the company at the time of the merger.

 

Dr. Deirdre Y. Gillespie, La Jolla’s CEO, stated, “The merger of La Jolla and Adamis will create a new specialty pharmaceutical company focused on the development and commercialization of therapeutic products for a variety of viral diseases, including hepatitis and influenza. We like the fact that in addition to the prefilled epinephrine syringe, Adamis has a pipeline including products for allergic rhinitis, asthma, and chronic obstructive pulmonary disease. We think Adamis is very unique in that it already has a product on the market and is expected to be profitable in the near-term.”

 

At the effective time of the merger, each outstanding share of Adamis common stock will be converted into the right to receive one (post-reverse stock split) share of La Jolla common stock. Adamis currently has approximately 46 million outstanding shares of common stock, excluding options, warrants and convertible securities. If the transaction is approved by the stockholders, immediately before the closing of the merger La Jolla will implement a reverse stock split; the precise ratio of the reverse stock split will be determined in accordance with the terms of the merger agreement and is dependent on La Jolla’s net cash at closing (reduced by the amount of La Jolla’s liabilities as of the closing date) and Adamis’ stock price over a period before the closing date subject to a variable discount (which in no event will yield a stock price that is less than $0.20 or greater than $1.50).

 

The percentage ownership of shares after the merger that will be held by persons who were La Jolla stockholders and Adamis stockholders, respectively, will depend on many factors, including without limitation the reverse stock split ratio for the La Jolla shares, the number of outstanding Adamis shares at the closing date of the merger and other factors. However, Adamis expects that after the closing of the merger, the persons who were La Jolla stockholders before the merger could hold approximately 5% - 30% of the outstanding shares of the combined company. Actual ownership percentages could be higher or lower than these estimates.

 

The merger agreement contains customary non-solicitation provisions restricting La Jolla’s and Adamis’ rights to negotiate or enter into other acquisition or sale transactions before the closing of the merger, subject to limited exceptions. The merger agreement also contains a number of customary representations, warranties and covenants of both parties. The merger agreement contains certain termination rights for both La Jolla and Adamis upon the occurrence of certain events, and further provides that upon termination of the merger agreement under specified circumstances, either party may be required to pay the other party a termination fee. The merger is intended to qualify for federal income tax purposes as a tax-free reorganization under the provisions of Section 368(a) of the U.S. Internal Revenue Code of 1986, as amended.

 

ABOUT ADAMIS PHARMACEUTICALS

 

Adamis Pharmaceuticals has two wholly owned subsidiaries, Adamis Laboratories and Adamis Viral Therapies. Adamis Labs expects to launch a series of niche prescription products in the allergy and respiratory therapeutic area, beginning with the Epinephrine Injection USP 1:1000 (0.3mg Pre-Filled Single Dose Syringe) product. Adamis Viral Therapies is focused on the development of patented, proprietary vaccine technology that Adamis believes may have the capability of generating a broad-based immunity for both B Cells (antibody) and T cells (cell mediated immunity). If successful, Adamis’ technology could lead to the development of new vaccines against a multitude of viruses, including chronic hepatitis and all forms of influenza. Shoreline Pacific has acted in an advisory role to Adamis during this transaction.

 

SUNESIS PHARMACEUTICALS INCORPORATED (NASDAQ: SNSS)

"Up 20.45% on Tuesday"

 

Detailed Quote: http://www.otcpicks.com/quotes/SNSS.php 

 

Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, voreloxin, in multiple indications to improve the lives of people with cancer.

 

SNSS News:

 

December 7 - Sunesis Presents Positive Phase 2 Clinical Data of Voreloxin in Acute Myeloid Leukemia at the American Society of Hematology 2009 Annual Meeting

 

Conference Call Scheduled for December 8 at 2:00 PM EST to Discuss ASH Data Presentations

 

Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) announced positive data from two Phase 2 clinical trials of the Company's lead drug candidate, voreloxin. The results highlight voreloxin's strong efficacy and safety profile when used as a single agent or in combination with chemotherapy in patients with difficult to treat acute myeloid leukemia (AML). The trial results were presented at the 51st American Society Hematology (ASH) Annual Meeting in New Orleans, LA. The presentations are available on the Sunesis website at www.sunesis.com.

 

"These results provide us with the efficacy and safety data to move voreloxin forward into pivotal testing," said Steven Ketchum, Ph.D., Senior Vice President of Research and Development at Sunesis. "Trial results show that the high rates of remission observed in both trials have translated into durable effects with meaningful preliminary overall survival results. With an anticipated median survival of three and a half to six months on currently available therapies, primary refractory and first relapse AML patients are particularly in desperate need of more effective treatment options. We look forward to discussing these data with the FDA in our End-of-Phase 2 meeting scheduled for the first quarter of 2010."

 

Phase 1b/2 Clinical Trial of Voreloxin in Combination with Cytarabine in Relapsed/Refractory (Abstract No. 645)

 

In an oral presentation, Jeffrey Lancet, M.D., Associate Member, Section Chief - Leukemia, Department of Hematologic Malignancies, at the H. Lee Moffitt Cancer Center & Research Institute and a clinical trial investigator, presented data from a Phase 1b/2 clinical trial testing voreloxin in combination with cytarabine, a widely used chemotherapy, in patients with relapsed or refractory AML. The trial is designed to evaluate the safety, pharmacokinetics and anti-leukemic activity of escalating doses of voreloxin when administered in combination with cytarabine given either as continuous infusion or as a two hour IV infusion. To date, 66 patients have been treated in the expansion Phase 2 populations of the trial, which includes primary refractory and first relapse AML patients. Of these, 64 patients were evaluable for efficacy outcomes.

 

* Among evaluable first relapse (n=36) and primary refractory patients (n=28), preliminary median overall survival is 7.8 months and the remission rate is 31% (complete remission [CR] 27%, complete remission without full platelet recovery [CRp] 2% and complete remission with incomplete recovery [CRi] 2%). Historical median overall survival data in primary refractory and first relapse patients on currently available chemotherapies range from 3.4 to 5.9 months.

 

* Voreloxin in combination with either bolus or continuous infusion cytarabine was generally well-tolerated. Infection-related toxicities were the most common Grade 3 or higher non-hematologic adverse events. In addition, Grade 3 or higher oral mucositis was observed.

 

* All-cause mortality among these patients was 1% at 30 days and 8% at 60 days.

 

* A recommended pivotal dose-regimen of voreloxin used in combination with cytarabine has been identified.

 

"Voreloxin has induced remissions in difficult to treat relapsed, primary refractory and relapsed/refractory AML patients," said Dr. Lancet. "Voreloxin used in combination with cytarabine has demonstrated meaningful anti-leukemic activity with an acceptable tolerability profile in these difficult-to-treat patients."

 

Phase 2 Clinical Trial of Single Agent Voreloxin in Newly Diagnosed Elderly AML (REVEAL-1 Trial) (Abstract No. 1037)

 

In a poster presentation, investigators presented data from the fully enrolled REVEAL-1 (Response Evaluation of VorEloxin in AmL) trial, a Phase 2 dose optimization trial of single agent voreloxin in previously untreated, elderly AML patients who are unlikely to benefit from standard induction chemotherapy. 113 AML patients have been treated in the trial, all of whom had at least one additional adverse risk factor at enrollment, including intermediate or unfavorable cytogenetics in the majority of patients. Median age for patients in the trial was 74 years. The trial includes three dosing schedules: Schedule A, once weekly for three weeks (n=29); Schedule B, once weekly for two weeks (n=35); and Schedule C, on days one and four at either 72 mg/m2 (n=29) or 90 mg/m2 (n=20).

 

* Median survival was 8.7 months in Schedule A; 5.8 months in Schedule B; and 7.3 months (preliminary) in Schedule C (72 mg/m2 on days one and four).

 

* Median duration of remission was 10.7 months and one year survival was 38% for Schedule A. For the other schedules, median duration of remission has not been reached and one year survival is too early to evaluate.

 

* Patients age 75 or older (N=49) with at least 1 additional risk factor at diagnosis, a population identified by the National Comprehensive Cancer Network (2010) AML Guidelines as having poor outcome to standard treatment, experienced a CR rate of 30% and a 30-day all-cause mortality of 5%. Survival in these patients was too early to evaluate.

 

* Based on trial results, Schedule C has been determined to be the recommended pivotal dose regimen. For Schedule C, response rates (CR and CRp) are 38%; 30- and 60-day all-cause mortality are 7% and 17% with improved tolerability over Schedule A.

 

"Voreloxin has demonstrated a unique combination of anti-leukemic activity and tolerability, important for patients who are unlikely to benefit from standard induction therapy," said Robert K. Stuart, M.D., Professor of Medicine, Division of Hematology/Oncology, Department of Medicine, Medical University of South Carolina, and an investigator in the Phase 2 clinical trial. "Particularly encouraging are the durable response, tolerability and promising survival results in the Schedule C group. I look forward to seeing further data from this trial as it matures, particularly voreloxin's durability and overall survival in Schedule C."

 

Conference Call and Slide Presentation Information

 

The company will host a conference call and webcast slide presentation December 8, 2009 at 2:00 PM EST to discuss the Company's new clinical data. Robert K. Stuart, M.D., Professor of Medicine, Division of Hematology/Oncology, Department of Medicine, Medical University of South Carolina, will join the Sunesis senior management team to review the updated data from the Company's Phase 2 studies of voreloxin. The call can be accessed by dialing 888-726-2443 (U.S. and Canada) or 913-312-1516 (international). To access the live audio webcast and accompanying slide presentation, or the subsequent archived recording, visit the "Investors and Media - Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company's website until December 22, 2009.

 

ABOUT VORELOXIN

 

Voreloxin is a first-in-class anticancer quinolone derivative, or AQD, a class of compounds that has not been used previously for the treatment of cancer. Voreloxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Voreloxin is currently being evaluated in a Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly AML patients and in a Phase 1b/2 clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML, as well as in an ongoing Phase 2 single-agent trial in platinum-resistant ovarian cancer.

 

ABOUT ACUTE MYELOID LEUKEMIA

 

AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The Leukemia and Lymphoma Society estimates that nearly 13,000 new cases of AML will be diagnosed and approximately 9,000 deaths from AML will occur in the U.S. in 2009. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.

 

JAYHAWK ENERGY INCORPORATED (OTCBB: JYHW)

"Up 22.86% on Tuesday"

 

Detailed Quote: http://www.otcpicks.com/quotes/JYHW.php

 

JayHawk Energy, Inc., a development stage company, engages in the exploration, acquisition, development, production, and sale of natural gas, crude oil, and natural gas liquids primarily from conventional reservoirs in North America. It owns interest in the Uniontown project covering 35,000 gross acres of non-producing coal bed methane natural gas reserves located in Bourbon County, Kansas. The company was founded in 2004 as Bella Trading Company, Inc. and changed its name to JayHawk Energy, Inc. in June 2007. JayHawk Energy, Inc. is based in Broomfield, Colorado.

 

JYHW News:

 

September 21 - JayHawk Announces Discovery of Proven & Dependable Production Capabilities and Extension of $800,000 Debenture

 

JayHawk Energy, Inc. (OTCBB: JYHW) (“JayHawk”) provides an operational update regarding its Southeast Kansas oil and gas projects namely the: (1) Uniontown project, located in Bourbon County, Kansas; (2) Girard project, Crawford County, Kansas; and (3) several other shallow oil opportunities within our existing acreage that can exploited via Enhanced Oil Recovery (EOR) (collectively the “Projects”). JayHawk previously entered into a joint venture with DK True Energy Development Limited (“True Energy”) and its affiliates whereby True Energy is to be the operator and will earn up to an 85% equity position in the Projects via an investment of $1.8 MM over a 3 year period.

 

ABOUT THE UNIONTOWN AND GIRARD PROJECTS

 

The Uniontown and Girard projects consist of mineral leases covering approximately 45,000 gross acres in Bourbon and Crawford Counties, Kansas within the mature Cherokee Basin. The current target for development within those projects is the shallow gas (75-300 m) potential of the area, although the leases are also held for potential future development of coal-bed methane (“CBM”) and conventional oil and gas resources. A preliminary resource estimate for these projects has been prepared by Questa Engineering Corporation of Golden, Colorado and is available on the JayHawk Energy website www.jayhawkenergy.com. There are in excess of 70 wells available for recompletion. With the current low gas price only 5 wells are currently producing with stabilized production being in excess of 105 mcf/day. True Energy has piloted 5 wells with its proprietary technologies including the Short Radius Stimulation (SRS) and the Gas Gun (modified propellant gun technology) in order to demonstrate its low cost completion & stimulation techniques (below $10,000 USD per well). It is expected that as natural gas prices firm up, the respective CBM wells can be rapidly brought on line both expeditiously and economically with additional drilling ensuing.

 

Shallow Oil Resources

 

Concurrent to completing its geological and reservoir due diligence on the “Home Run” Kansas CBM project, True Energy has further delineated significant oil reservoirs that have been over-looked or were prematurely shut-in during the 1980s and now provide an opportunity to restart that project as much of the infrastructure is in place.

 

The Home Run project areas are located on the Missouri side of the prolific Cherokee Basin, known for shallow oil saturated sandstones. For optimum recovery the projects require waterflooding with additional chemical flooding in order to both drive the hydrocarbons from the reservoir into the production well bore and to reduce the residual oil within the reservoir. The water chemical mixture is introduced by a number of injector wells drilled within the project area on a “five spot pattern” with four production wells for each injector well.

 

The eastern side of the Cherokee Basin is estimated to contain between 1.8 and 8 billion barrels of oil in place based on published reports from the United States Geological Survey (“USGS”) and Missouri Department of Natural Resources Survey.

 

Following its analysis of the region, True Energy now has an increased understanding of the characteristics of the project acreage and has demonstrated there are several reservoirs present. All of the reservoirs discovered target the Upper and Lower Bartlesville formations and which possess excellent porosity and permeability with an API oil gravity ranging from 28 to 33. True Energy will be working to confirm the placement and rollout of several waterflood commercial pilots in the area.

 

JayHawk CEO Lindsay Gorrill states “we are extremely pleased by this outcome, these developments provide a significant increase in the resource base of JayHawk that was not expected during our initial due diligence phase in Kansas. This has provided the company the ability to take advantage of both rising oil and gas prices, while staying within our stated goals of acquiring low cost, near term production opportunities in the US oil and gas market.”

 

The company has also successfully negotiated the extension, to July 31, 2010, a $800,000 debenture payable to Starshell Consultants.

 

BIOTIME INCORPORATED (OTCBB: BTIM)

"Up 20.58% on Tuesday"

 

Detailed Quote: http://www.otcpicks.com/quotes/BTIM.php

 

BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. BioTime develops and markets research products in the field of stem cells and regenerative medicine through its wholly owned subsidiary Embryome Sciences, Inc. BioTime’s subsidiary OncoCyte Corporation focuses on the therapeutic applications of stem cell technology in cancer. BioTime also plans to develop therapeutic products in China for the treatment of ophthalmologic, skin, musculo-skeletal system and hematologic diseases, including the targeting of genetically modified stem cells to tumors as a novel means of treating currently incurable forms of cancer through its subsidiary BioTime Asia. In addition to its stem cell products, BioTime markets blood plasma volume expanders and related technology for use in surgery, emergency trauma treatment, and other applications. BioTime's lead product, Hextend®, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements.

 

BTIM News:

 

December 4 - BioTime CEO Dr. Michael West to Ring The Opening Bell at the New York Stock Exchange

 

BioTime, Inc. (NYSE Amex: BTIM) Chief Executive Officer Michael D. West, Ph.D. will ring The Opening Bell at the New York Stock Exchange at 9:30 a.m. Eastern on Tuesday, December 8, 2009. Executives and guests of BioTime will also be at the ceremony to celebrate the company's recent listing on the NYSE Amex. Trading of BioTime’s common shares and warrants commenced on the NYSE Amex on Friday, October 30, 2009 under the ticker symbols “BTIM” for the common shares and “BTIM.WS” for the warrants.

 

The bell ringing will be webcast live on www.nyse.com and live to the jumbo screen on the W Hotel in Times Square. Both live and archive links for the bell ringing will also be posted on BioTime’s website at www.biotimeinc.com.

 

MESA AIR GROUP INCORPORATED (NASDAQ: MESA)

"Up 12.85% on Tuesday"

 

Detailed Quote: http://www.otcpicks.com/quotes/MESA.php

 

Mesa Air Group, Inc., through its subsidiaries, provides scheduled passenger and airfreight services. It carries passengers, as well as freight and express packages on its passenger flights. The company also has interlined small cargo freight agreements with various other carriers. In addition, Mesa Air Group contracts with the U.S. Postal Service for carriage of mail to the cities it serves. Further, it occasionally operates charter flights. As of September 30, 2007, the company operated a fleet of 182 aircraft with approximately 1,100 daily departures to 184 cities in the United States, the District of Columbia, Canada, the Bahamas, and Mexico. Mesa Air Group was founded in 1980 and is headquartered in Phoenix, Arizona.

 

MESA News:

 

November 6 - Mesa Air Group, Inc. Announces Update on CRJ-200s Operating at United Airlines

 

Mesa Air Group, Inc. (Nasdaq: MESA) announced that the timeframe for United Airlines to exercise its renewal rights with respect to extending Mesa's operation of 26 CRJ-200 aircraft under its code-share agreement with United Airlines has expired. Mesa plans to work with United Airlines on an orderly transition plan, but, in any event, the date of exit from service is expected to be no later than April 30, 2010.

 

See the Company's disclosure in its Form 10-Q for the quarterly period ended June 30, 2009, which was filed on August 10, 2009, for a complete discussion of the Company's agreement with United and its contribution to the Company's revenue.

 

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