Dallas, TX 11/10/2007 2:45:19 AM
OTCPicks.com Daily Market Movers Digest Midday Report for November 9th CNGJ, CRTX, DKSC, EFGU
Our Stocks to Watch today include Canam Energy Inc. (OTC: CNGJ), Critical Therapeutics, Inc. (NASD: CRTX), Dakshidin Corporation (OTC: DKSC), Empire Film Group (OTC: EFGU)
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CANAM ENERGY (OTC: CNGJ)
"Up 10.00% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/CNGJ.php
Canam Energy Inc. is a rapidly emerging mineral exploration company with a corporate mandate to define and explore mineral properties worldwide. The company will acquire highly prospective properties, predominately uranium, that offer the opportunity for expansion and development. Canam Energy Inc. currently has properties in the Sudbury Basin in Ontario and Mongolia.
CNGJ News:
November 8 - Canam Energy Inc. (CNGJ) Announces Appointment of Senior Geophysical and Mine Technician
Canam Energy Inc. (OTC: CNGJ), "The Company", an exploration company aggressively pursuing mineral properties in the Uranium industry announced that it has added to its advisory board Mr. Murray Gauthier. Mr. Gauthier comes with an extensive background in mining and exploration, including Senior Geological Technician for Cameco Corporation, the largest Uranium producer in the world, on their U/G Uranium Mine from 1996- 2002. http://www.cameco.com
Mr. Gauthier will assist in the company's corporate goals of acquiring new properties as well as exploration of current and any future land holdings.
An extensive exploration program for the companies holdings including geological and radio-metric surveying and ultimately drilling is planned for the 2007-2008 season.
The company is confident that Quebec represents a promising opportunity for uranium exploration and its properties are located in a prolific area with many operational camps and an operating uranium mine in the immediate vicinity. The increased commodity price for uranium coupled with the growing global demand also fits with the company's strategy of mobility and diversification.
CRITICAL THERAPEUTICS (NASD: CRTX)
"Up 4.17% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/CTRX.php
Critical Therapeutics, Inc., a biopharmaceutical company, engages in the development and commercialization of products to treat respiratory, inflammatory, and critical care diseases linked to the body's inflammatory response. It markets ZYFLO, a tablet formulation of zileuton, which is used for the prevention and chronic treatment of asthma in adults and children 12 years of age or older in the United States. The company is also developing a controlled-release formulation of zileuton, or zileuton CR, a tablet designed to be taken twice daily, for the prevention and chronic treatment of asthma; and zileuton injection, which is in Phase II clinical trials for use in emergency room or urgent care centers for patients who suffer acute exacerbations of asthma. zileuton also has therapeutic benefits in treating various diseases and conditions, including acute asthma exacerbations and chronic obstructive pulmonary disease. In addition, Critical Therapeutics has a preclinical program, alpha-7, for oral anti-cytokine therapy for acute and chronic inflammatory diseases, such as asthma and rheumatoid arthritis. It has collaboration with MedImmune, Inc. on preclinical development of monoclonal antibodies directed toward a cytokine, called HMGB1, or high mobility group box protein 1, for the development of products to treat diseases mediated by the inflammatory response; CyDex, Inc. for the clinical development and marketing of the injectable formulation of its asthma drug Zileuton; and Beckman Coulter, Inc. on the development of a diagnostic directed toward measuring HMGB1 in the bloodstream. The company was founded in 2000 as Medicept, Inc. and changed its name to Critical Therapeutics, Inc. in 2001. Critical Therapeutics is based in Lexington, Massachusetts.
CRTX News:
November 8 - Critical Therapeutics Reports Financial Results for the Three and Nine Months Ended September 30, 2007
Company Initiates Review of Business Strategy and Strategic Alternatives
Critical Therapeutics, Inc. (NASD: CRTX) reported financial results for the three and nine months ended September 30, 2007. The Company also announced that it is currently considering potential changes to its business strategy and has engaged an investment bank to advise it on potential strategic alternatives.
“We have accomplished of a number of significant milestones during the past twelve months and do not believe that our current valuation is reflective of the true value of our assets,” said Frank Thomas, President and Chief Executive Officer. “Therefore, we have initiated a comprehensive process to evaluate other strategies that might better maximize the value of our assets and ultimately realize value for our shareholders.”
For the three months ended September 30, 2007, the Company posted a net loss of $7.8 million, or $0.18 per share, based on 42.6 million weighted average common shares outstanding. This compares with a net loss of $8.9 million, or $0.26 per share, for the same period in 2006, based on 34.3 million weighted average shares outstanding. The increase in common shares outstanding resulted primarily from the Company’s registered direct offering of 7.5 million shares in October 2006.
During the third quarter of 2007, product sales of ZYFLO® (zileuton tablets), the Company’s immediate-release formulation of zileuton, and twice-daily ZYFLO CRTM (zileuton) extended-release tablets totaled $3.1 million, compared with product sales of ZYFLO that totaled $1.9 million in the third quarter of 2006, an increase of 66 percent. Critical Therapeutics and Dey, L.P. (DEY), a subsidiary of Mylan Inc., launched ZYFLO CR in the U.S. on September 27, 2007 for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. Third quarter 2007 sales of ZYFLO CR included initial shipments to wholesalers of approximately 4,300 units, representing approximately $870,000 in revenue.
Cash and short-term investments totaled $34.0 million as of September 30, 2007, compared with $40.5 million at June 30, 2007 and $40.2 million at September 30, 2006. Net cash expenditures in the third quarter of 2007 were $6.4 million, compared with net cash expenditures of $12.0 million in the third quarter of 2006 and $5.5 million in the second quarter of 2007. As of September 30, 2007, the Company had 43.1 million common shares outstanding, excluding warrants and stock options.
Review of Business Strategy and Future Operations
The board of directors and management are seeking to maximize the value of the Company’s commercial organization and product development programs. Together, they are currently evaluating a range of strategic alternatives that could result in potential changes to the Company’s current business strategy and future operations. The alternatives could include one or more potential transactions, such as the sale or divestiture of certain assets of the Company, the merger or sale of the Company, or other strategic transactions. The Company has engaged Lazard to advise it in considering potential strategic alternatives. Pending any decision to change strategic direction, the Company is continuing its commercial and development activities in accordance with its existing business strategy with an increased focus on the Company’s cash position.
There can be no assurance that the evaluation of strategic alternatives will lead to a change in the Company's current business strategy or result in one or more transactions. The Company does not intend to comment on the status of its evaluation of strategic alternatives unless and until there are material developments. As a result of potential changes in the strategic direction of Critical Therapeutics, the Company does not have sufficient information at this time to estimate the impact these potential changes or future transactions may have upon the operations of the Company and therefore is withdrawing its previously provided financial guidance.
Recent Developments
Since the end of the second quarter of 2007, Critical Therapeutics:
Began promoting ZYFLO CR in the U.S. together with its co-promotion partner, DEY. With a combined sales force of approximately 240 representatives, Critical Therapeutics and DEY are marketing ZYFLO CR to a targeted group of allergists, pulmonologists and primary care physicians. ZYFLO CR and ZYFLO are the only FDA-approved leukotriene synthesis inhibitors for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older.
Began promoting PerforomistTM (formoterol fumarate) Inhalation Solution, DEY’s product for the long-term maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD) on October 8, 2007.
Initiated three clinical studies:
1. In July 2007, Critical Therapeutics initiated a Phase IV clinical trial designed to evaluate the efficacy of ZYFLO CR as an add-on therapy in asthma patients whose symptoms are uncontrolled despite taking moderate doses of inhaled corticosteroids.
2. In October 2007, the Company initiated a Phase I clinical trial to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profile of an oral single dose of the R(+) isomer of zileuton in healthy subjects.
3. In October 2007, Critical Therapeutics initiated a Phase II clinical trial to assess the effect on pulmonary function, safety, tolerability and the pharmacokinetic profile of the injectable formulation of zileuton (zileuton injection).
Commenced enrollment of patients in the LEUKO study, a randomized, double-blind, placebo-controlled clinical trial designed to examine the safety and efficacy of ZYFLO, in addition to usual care, for the treatment of acute exacerbations of COPD in 520 patients requiring hospitalization. The LEUKO study is being sponsored and funded by the National Heart, Lung and Blood Institute, part of the National Institutes of Health.
Continued to execute on its publication strategy with the announcement of two peer-reviewed publications:
1. Data from a Phase III clinical trial that was conducted primarily to evaluate the efficacy of ZYFLO CR compared with placebo was published in the Annals of Allergy, Asthma & Immunology.
2. Data from a 12-month, open-label, safety surveillance study that was designed to evaluate the long-term safety of ZYFLO and establish appropriate monitoring guidelines for liver function testing (LFT) were published in the Drug Safety edition of the Official Journal of the International Society of Pharmacovigilance.
Financial Results for the Three Months Ended September 30, 2007 and 2006
Total revenue for the three months ended September 30, 2007 was $3.2 million, compared with $4.4 million for the same period in 2006.
Revenue for the third quarter of 2007 included:
Sales of ZYFLO and ZYFLO CR that accounted for $3.1 million in revenue, or 97 percent of total revenue. This compares with revenue from sales of ZYFLO of $1.9 million, or 43 percent of total revenue, in the third quarter of 2006. The 66 percent increase in product revenue is primarily attributable to the recognition of $870,000 in net product sales from ZYFLO CR, which was launched on September 27, 2007, and an 11 percent increase in ZYFLO’s wholesale acquisition price compared to the corresponding period in 2006. Starting January 1, 2007, the Company began recognizing revenue from product sales when the product was shipped to third-parties, less an estimate of expected product returns. Prior to this change, the Company recognized revenue from product sales only when the product was dispensed through patient prescriptions.
Collaboration and license revenue of $93,000 from Critical Therapeutics’ HMGB1 collaboration with MedImmune, Inc. and its license agreement with Innovative Metabolics, Inc. to develop medical device approaches to stimulating the vagus nerve. This compares with collaboration and license revenue of $2.5 million in the third quarter of 2006. The decrease is associated with a decline in collaboration revenue from MedImmune. The Company’s future collaboration and license revenue from the MedImmune, Beckman Coulter and Innovative Metabolics agreements will primarily be recognized in periods when milestones are achieved, as all of the up-front payments under these agreements have now been fully amortized or recorded.
Total operating expenses for the three months ended September 30, 2007 totaled $11.4 million, compared with $13.8 million for the same period in 2006, a decrease of 18 percent.
Total operating expenses for the third quarter of 2007 included:
Cost of products sold that totaled $1.2 million, compared with $267,000 in the third quarter of 2006. Costs of products sold in the third quarter of 2007 consisted of manufacturing, distribution and other costs related to ZYFLO and ZYFLO CR and royalties paid to Abbott and SkyePharma related to ZYFLO and ZYFLO CR, as well as reserves established for excess or obsolete inventory. The Company recorded $219,000 of inventory write-offs in the third quarter of 2007 and did not record any inventory write-offs in the third quarter of 2006. Gross margins from product sales were 61 percent in the third quarter of 2007, compared with 86 percent in the third quarter 2006. In addition to the inventory write-offs in the third quarter of 2007, the decrease in gross margins is primarily related to higher manufacturing costs for ZYFLO CR and additional royalty obligations to SkyePharma for use of its controlled-release technology in ZYFLO CR. The Company also granted certain launch incentives to wholesalers during the third quarter of 2007 that resulted in lower margins for ZYFLO CR.
Research and development (R&D) expenses that decreased $2.8 million, or 42 percent, to $3.9 million, compared with $6.7 million in the third quarter of 2006. This decrease was primarily due to a reduction in the number of employees performing R&D functions and nonrecurring milestone payments that were made in the third quarter of 2006. These decreases were partially offset by additional clinical costs related to the ZYFLO CR Phase IV clinical trial initiated in July 2007.
Sales and marketing expenses that totaled $3.6 million, compared with $3.9 million in the third quarter of 2006. The decrease was primarily associated with the 2006 reduction in the Company’s sales force, partially offset by promotional and other marketing expenses associated with the launch of ZYFLO CR and the Company’s marketing obligations under its co-promotion agreement with DEY.
General and administrative (G&A) expenses that totaled $2.7 million, compared with $2.9 million in the third quarter of 2006. The decrease was primarily due to a reduction in the number of employees performing G&A functions.
Financial Results for the Nine Months Ended September 30, 2007 and 2006
Total revenue for the nine months ended September 30, 2007 was $10.1 million, compared with $10.2 million for the same period in 2006. Product sales of ZYFLO and ZYFLO CR accounted for $8.3 million of revenue during the first nine months of 2007, compared with $4.7 million of product sales for ZYFLO during the first nine months of 2006, an increase of 76 percent. Starting January 1, 2007, the Company began recognizing revenue from product sales when the product was shipped to third-parties, less an estimate of expected product returns. Prior to this change, the Company recognized revenue from product sales only when the product was dispensed through patient prescriptions.
Critical Therapeutics’ collaboration with MedImmune and its license agreements with Beckman Coulter and Innovative Metabolics accounted for $1.8 million in revenue during the first nine months of 2007, compared with $5.4 million from the MedImmune collaboration and the Beckman Coulter license agreement during the first nine months of 2006.
Total operating expenses for the nine months ended September 30, 2007 were $37.0 million, compared with $52.1 million for the same period in 2006, a decrease of 29 percent. The decrease was primarily due to a reduction in the number of employees and certain R&D programs.
Research & Development Update
Critical Therapeutics’ preclinical and clinical development programs continue to progress with the initiation of three clinical trials during the third quarter of 2007.
ZYFLO CR Phase IV Trial
In July 2007, the Company initiated a Phase IV clinical trial to evaluate ZYFLO CR as an add-on therapy in asthma patients to support sales and marketing efforts for ZYFLO CR. The randomized, double-blind, placebo-controlled trial involving 400 patients will assess the effect of ZYFLO CR on lung function, asthma control and symptomatic response in adults whose asthma is not effectively controlled with moderate doses of inhaled corticosteroids.
Zileuton Injection Phase II Trial
The Company plans to develop an injectable formulation of zileuton for adjunctive use in emergency room or urgent care settings for acute asthma patients. In October 2007, the Company initiated a Phase II clinical trial focused on assessing efficacy and identifying the optimal dose to be tested in Phase III clinical trials. A total of 36 patients with stable chronic asthma are scheduled to be enrolled in the randomized, multi-center, double-blind, three-period crossover trial.
R(+) Zileuton Phase I Trial
In October 2007, Critical Therapeutics initiated a Phase I clinical trial to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profile of an oral single dose of the R(+) isomer of zileuton. A total of 12 healthy subjects were enrolled in the randomized, open-label, single-center, two-period crossover trial. The Company believes that the successful development of the R(+) isomer could lead to potential dosing improvements for patients, an enhanced product profile for zileuton for the treatment of asthma and provide for possible development opportunities in other inflammatory diseases, including COPD and nasal polyps.
Alpha-7 Program
The Company’s alpha-7 nicotinic receptor program, which is directed at the discovery and development of novel small molecule drugs for the treatment of inflammation, has selected a lead compound that is currently in preclinical development. The Company believes that this innovative anti-inflammatory approach has the potential for broad applications in both acute and chronic inflammatory diseases. The Company expects to begin GLP toxicology studies in 2008 and submit an Investigational New Drug (IND) application in the second half of 2008.
HMGB1 Program
The Company is collaborating with MedImmune on the development of a human monoclonal antibody to the cytokine HMGB1. The collaboration has identified potential clinical candidates that have shown efficacy in pre-clinical models of arthritis and lupus. The joint development team expects its next step to be the selection of a clinical candidate for the development of HMGB1 antibodies for inflammatory diseases, such as sepsis, lupus or rheumatoid arthritis.
DAKSHIDIN CORPORATION (OTC: DKSC)
"Up 14.29% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/DKSC.php
Dakshidin Corporation through its wholly owned subsidiary, RESTEC International Inc. produces the world's most powerful pumping windmill. Throughout the world, especially in developing countries, there is a dire need for water to fulfill basic human self-sufficiency demands. In most cases, the problem is not the lack of available water, but the cost and reliability of obtaining it. The RESTEC Windmill is the renewable, cost-effective and environmentally friendly solution for the world's water crisis.
DKSC News:
November 9 - Dakshidin to Sign Memorandum of Understanding With Bengbu Government
Dakshidin Corporation (OTC: DKSC) (www.dakshidin.com) and its wholly owned subsidiary, Restec International Inc., producers of world's most powerful pumping windmill, announced that its President and CEO, Mr. Nick Laroche, will travel to China today in order to sign a Memorandum of Understanding (MOU) with the Municipal Government of Bengbu in the Province of Anhui of the People's Republic of China. This MOU outlines the intended Joint Venture with Huasheng (Bengbu) Environmental Energy Development Ltd.
"Securing this Joint Venture with the Bengbu Government has significant opportunities for Dakshidin. This relationship will position Dakshidin as a prominent player in one of the most prime development areas of renewable energy and water resources in China. The partnership will further allow Dakshidin to efficiently move forward with the Green Village Venture in the province of Anhui, China, as mentioned in the November 6th, 2007 press release," stated Nick Laroche, President and CEO of Dakshidin Corporation.
Proficiency testing on the Restec Mark 10 windmill has been carried out at the Texas A&M University and the Alberta Department of Agriculture. Field tests within Mexico, China and Arizona have concluded that the Restec Mark 10 windmill produces more water at a lower cost than any other windmill tested.
The RESTEC Windmill is the world's best renewable, cost-effective and environmentally friendly solution for the world's water and energy crisis.
EMPIRE FILM GROUP (OTC: EFGU)
"Up 13.64% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/EFGU.php
Empire Film Group, Inc. ("EFG") is a new independent film finance, production, and distribution company led by a management team with over 20 years of experience in development, production, distribution, finance and marketing of feature films and television programming. The group has filmed in various locations worldwide including the United States, Canada, the Caribbean, Central and South America and Europe. The Company has the unique financing advantage of being able to receive Canadian subsidies, tax incentives, rebates and financing through its ability to produce Canadian Content film and television projects. Learn more about Empire Film Group by visiting www.empirefilmgroup.com.
EFGU News:
November 9 - Empire Film Group Retains AGORACOM Investor Relations
Empire Film Group (OTC: EFGU) ("Empire Film") (www.empirefilmgroup.com) announced it has retained the services of AGORACOM Investor Relations ("AGORACOM") (www.agoracom.com) to provide investor relations services.
The objective of this agreement is two-fold. First, to create effective communication between Empire Film, its shareholders and the investment community through AGORACOM's Internet based investor relations system. Effective immediately, a customized and monitored Empire Film IR HUB will allow both Empire Film and AGORACOM to communicate with all investors simultaneously, anytime and in real-time, while providing shareholders with equal access and complete transparency to all investor relations communications. The IR HUB will also provide one-click access to all critical Empire Film IR information, as well as an executive audio address. In addition, the IR HUB provides investors with a monitored discussion forum for the purposes of constructive and high-quality discussion about the Company that is free of spam, bashing, hyping and profanity.
Second, AGORACOM will be responsible for raising Empire Film awareness amongst retail investors for the purposes of attracting new and prospective shareholders. As an exclusive small-cap content provider to Yahoo Finance Canada, AOL Finance Canada and every BlackBerry device on the planet, AGORACOM will provide Tier-1 financial coverage of all meaningful Empire Film press releases.
AGORACOM will be fully responsible for creating, implementing and executing an investor relations strategy, the consolidation of which will save management a considerable amount of time, effort and expense, allowing them to focus on core business operations, while significantly improving shareholder communications.
Empire Film Group CEO, Dean Hamilton Bornstein, stated, "Empire Film believes the time has now come to communicate with shareholders and the investment community. The solution provided by AGORACOM fulfils our need to manage and execute an IR strategy in a cost efficient manner, while providing our management team with the ability to focus on executing the business plan. Our shareholders and Company will benefit greatly from near real-time communications, regularly planned updates and increased exposure."
For all future Empire Film investor relations needs, investors are asked to visit the Empire Film IR Hub at http://www.agoracom.com/IR/EmpireFilm where they can post questions and receive answers within the same day, or simply review questions and answers posted by other investors. Alternatively, investors are able to e-mail all questions and correspondence to EFGU@agoracom.com where they can also request addition to the investor e-mail list to receive all future press releases and updates in real-time.
About AGORACOM Investor Relations Corp.
AGORACOM Investor Relations is North America's leading outsourced investor relations firm for small-cap companies. AGORACOM's exclusive IR HUB delivers two-way investor relations and communications that provides 100% transparency, accessibility, equality and near real-time communications for all shareholders and the investment community.
AGORACOM has specialized in small-cap investor relations since 1997 and is the exclusive provider of all small-cap content to Yahoo Finance Canada, The AOL Small Cap Channel and every Blackberry device on the planet.
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