Our Stocks to Watch today include San West Inc. (OTCBB: SNWT), Biomagnetics Diagnostics Corp. (OTC: BMGP), AGR Tools Inc. (OTCBB: AGRT), Vega Promotional Systems Inc. (OTC: VGPR), Lux Energy Corp. (OTCBB: LUXED), OrderPro Logistics Inc. (OTC: OPLO), Miller Petroleum Inc. (OTCBB: MILL), Bionovo Inc. (Nasdaq: BNVI), AspenBio Pharma Inc. (Nasdaq: APPY), Mobile Media Unlimited Holdings Inc. (OTC: MMUH) and La Jolla Pharmaceutical Co. (Nasdaq: LJPC).
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SAN WEST INCORPORATED (OTCBB: SNWT)
Detailed Quote: http://www.otcpicks.com/quotes/SNWT.php
Company Profile: http://www.otcpicks.com/san-west-inc.htm
San West designs, manufacturers, sells and repairs off-road buggies, and additionally provides aftermarket performance products and accessories for off-road buggies; products are sold via three divisions: at retail store locations; via the online store and; through its growing dealer network. Buggy repair services are sold and fulfilled at the Santee California retail location.
SNWT News:
December 29 - San West Inc. Releases Significant Milestones for 2009 and 2010 Outlook
Management Reflects on a Transformational 2009; Outlines Aggressive Growth Initiatives for 2010
San West Inc. (OTCBB: SNWT), an emerging leader in the design, manufacture, sales and repair of off-road recreational vehicles, provides a business update and reiterated its expectation that 2010 will be another transformational year as the company pushes forward with plans to become a leading global off-road sports producer and retailer.
2009 Business Review
Operational Developments:
* Entered the public marketplace via reverse merger with Human Bio-Systems, Inc. in early June and began trading on the OTC Bulletin Board under the symbol HBSY, and changed corporate name and ticker change to San West Inc. and SNWT in late September.
* Launched a new and improved Buggy World website equipped with an e- commerce store to further expand our market reach and broaden our offering and purchasing options for customers.
* Became the exclusive TrophyKart dealership for San Diego County in an agreement expected to generate between $150,000 to $250,000 in annual sales and drastically boost and improve brand notoriety, particularly among the younger demographic.
* Partnered with CountyImports.com, the second-largest online retailer of off-road vehicles and accessories, in an agreement expected to add at least $3,200,000 in annual revenues to San West's top line and offset the seasonality of our sales levels.
* Subsequently launched an enhanced version of CountyImports.com and announced that sales generated through the website between 11/17/08 and 12/18/09 were approximately $150,000, higher than the corresponding period of 2008, a record year for CountyImports.com.
* Reported revenues for the third quarter of $217,099, an increase of 53.4% and gross profits or $146,336 , representing a gross profit margin of 26.8%.
* Announced that fourth quarter 2009 will by far be the greatest in corporate history.
* Established a promotional credit program — “The RPM Card” — to help offset the negative impact of the consumer credit meltdown by providing financing to customers with less than stellar credit ratings.
* Acquired non-exclusive sales & marketing rights for leading off-road sporting brands including Fox Racing, Joiner, and Thor.
Market-Related Developments:
* Share price has surged from less than one cent to a 52-week high of $1.71 on 10/12 ($0.35 split adjusted).
* Executed a 5 for 1 forward stock split in November of 2009 with the intent of strengthening shareholder value by facilitating increased trading among retail investors.
* Secured $10,000,000 in equity financing from an institutional investor during December which will enable San West to more aggressively pursue synergistic acquisitions.
* Announced a consulting agreement with Hayden IR, a leading North American investor relations firm with a proven track record of transforming micro- cap firms into NYSE and Nasdaq-traded companies.
2010 Outlook
1) 2010 will be another transformational year for San West Inc. During 2009, San West launched a number of strategic initiatives that helped lay the foundation for a premier international off-road sports firm and positioned the company to generate annual revenues in the $6,000,000 to $8,000,000 next year. We strongly believe that our continued relentless pursuance of opportunities that hold the potential to drive growth — both organically and via acquisition — during 2010 will help boost annual revenues above initial expectations.
2) We recently obtained $10,000,000 in equity financing which provides an ideal complement to our extremely successful and assiduous expansion initiatives. This capital injection will allow San West to grow our business in ways that were quite recently unimaginable. Corporate/competitor buyouts, major real estate acquisitions, massive advertising investments, expensive product and service development, and sponsorship of major industry events are all now economically feasible to some extent.
3) We are building a one-stop off-road sports superstore, both online and at our first Buggy World brick & mortar location — and will continue to pursue business ventures that will help broaden our global consumer reach. A few potential avenues for near-term expansion include but are not limited to fortifying existing online sales infrastructure, establishing additional retail locations in "hot" off-road markets, and expanding into new product markets such as personal watercraft (PWC) and motorcycles.
4) From a stock market perspective, our share price has matured significantly over the past 6 to 12 months. We have aligned our organization with some of the most highly esteemed financial services organizations in the world to help create shareholder value, provide maximum transparency into our operations, to articulate our unique value proposition and relay our growth story to the masses, and establish a line of communication to institutional investors.
5) At this point, we would like to thank our faithful shareholders for their interest in 2009 and reiterate our dedication to making 2010 another lucrative year for them and San West Inc. together. We wish everyone a very happy holiday season and a prosperous new year and also look forward to updating the public on our material developments as they arise.
December 28 - San West Inc. CEO Interviewed by Stockgoodies.com
Radio Interview Discusses Growth Strategy and Strategic Progress to Date in Effort to Build Global Off-Road Motorsports Leader
San West Inc. (OTCBB: SNWT), an emerging leader in the design, manufacturing, sales and repairs of off-road buggies, announced the availability of a recent interview conducted with President & CEO Frank Drechsler. Stockgoodies.com, a G6 Stocks community, conducted the interview and posted it on its homepage at www.stockgoodies.com.
Frank Drechsler, San West Inc. Chief Executive Officer, stated, "San West continues to benefit from increased media attention, due in large part to our consolidation of the outdoor and off-road racing industry as well as our projected growth for the fourth quarter and 2010. We have made tremendous progress in our efforts to create a one-stop-shop for all off-road motorsports enthusiasts, including buggies, scooters, ATVs and personal watercraft. We are excited for our prospects as we look into 2010 and beyond and we are eager to share our vision and discuss our progress with investors."
BIOMAGNETICS DIAGNOSTICS CORPORATION (OTC: BMGP)
"Up 7.14% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/BMGP.php
Company Profile: http://www.otcpicks.com/biomagnetics-diagnostics/biomagnetics-diagnostics.htm
Biomagnetics Diagnostics Corporation is an advanced medical device and biotechnology company. The Company's revolutionary diagnostic systems, which are based on advanced magnetics, test for any viral or bacterial disease using any body fluid. The Company's technology allows laboratories to perform far more tests in the same amount of time it takes to do a single test. The HTS-MTP platform is designed to detect the actual virus and viral load in body fluids and not just simply screen for the presence of viral antibodies.
BMGP News:
December 28 - Biomagnetics to Become Fully Reporting; CEO Comments on Corporate Growth Plans and Strength of Balance Sheet
Biomagnetics Diagnostics Corp. (OTC: BMGP), a developer of revolutionary diagnostic systems and technology for HIV, hepatitis, tuberculosis, and malaria detection, announced it is instituting several actions to become a fully reporting organization, improve transparency to investors and migrate the trading of its common shares to the over-the-counter market. Additionally, corporate management is expressing confidence in achieving growth objectives for 2010.
“With the growth we expect during 2010 it will be important for us to provide full transparency to our investors and other stakeholders," commented Clayton Hardman, CEO of Biomagnetics Diagnostics. “Toward this aim, we have begun implementing plans to complete a full financial audit and to file these audit results with both Pink OTC Markets, Inc. and the Securities and Exchange Commission. We expect these actions to allow us to not only become a fully reporting organization, but also to make us eligible to trade our shares on the OTC market.
These actions include the completion of a full financial audit and the filing of financial disclosure information with Pink OTC Markets Inc. and the U.S. Securities and Exchange Commission. Additionally, the Company will be working with several broker-dealers on Rule 15c2-11 documentation for submission to FINRA in order to receive OTCBB quotation clearance.
“Our balance sheet remains very strong with a meaningful cash balance and minimal debt. We have been able to accomplish this with only very minimal fund-raising activities. This has allowed us to keep the number of total outstanding shares at only approximately 64 million. While we do not anticipate the need to raise growth capital, as our working capital balances are already robust, it is very comforting for us to have the strong backing of our shareholders, many of whom are eager to provide us additional growth capital should it be required. Simply put - our financial position is very strong, which will allow us to aggressively implement our growth strategies. With a total market capitalization of approximately $9 million, we believe our common shares are significantly undervalued.”
“Mr. Hardman continued, “While we realized significant accomplishments in the last four months of 2009, we expect the acceleration of developments in the first half of 2010. During the first quarter, we expect to enter into several certifications in
According to the World Health Organization, some 3.2 billion people, or about half the world's population is at risk of malaria transmission in 107 countries and territories worldwide. While there are between 350 million and 500 million new cases of malaria each year, there are very few reliable and field deployable diagnostic tools available. In the case of malaria, early detection substantially improves treatability and survivability. Field deployable Integrated Optical Biosensor Systems (IBOS), such those Biomagnetics Diagnostics is planning to soon introduce hold the promise to significantly speed the diagnostic testing process and to meaningfully lower costs and improve lives.
AGR TOOLS INCORPORATED (OTCBB: AGRT)
Detailed Quote: http://www.otcpicks.com/quotes/AGRT.php
Company Profile: http://www.otcpicks.com/agr-tools.htm
As a global leader in the manufacturing of high quality diamond tools, AGR Tools has been serving the construction and natural stone industries worldwide since 1983. AGR Stone & Tools USA, Inc. is the only manufacturer of a complete line of diamond tools designed for maximum performance for each application. Our products include turbo blades, polishing pads, cup wheels, core bits, tile blades, masonry blades, concrete blades, CNC tooling, engineered stone products and other high-end diamond tools.
AGRT News:
December 22 - AGR Expands Distribution Network to
AGR Tools, Inc. (OTCBB: AGRT) announces that AGR Stone & Tools USA, Inc., with which AGR Tools, Inc. has entered into a binding share exchange agreement, has expanded its distribution network into Nashville and the Middle Tennessee markets. With a population of approximately two million people and a multi-million dollar diamond tool market, the territory serviced by this addition will allow the company to continue increasing its presence in
AGR Stone & Tools USA, Inc.'s entry into the
As the only major manufacturer of diamond tools that markets and distributes its products directly to customers, AGR Stone & Tools USA, Inc. has a major advantage over its competition. By selling directly, its goal is to control a quarter of the approximately $8 billion North American diamond tool market. "As our distribution network continues to grow, that goal is becoming more and more a reality," noted Rock Rutherford, the CEO of AGR Stone & Tools USA, Inc.
ABOUT AGR STONE & TOOLS
AGR Stone & Tools USA, Inc. is a major supplier of diamond tools and adhesives. It specializes in producing consumable tools for the natural stone, engineered stone, concrete and masonry industries. Its goal is to provide its clients with superior quality products, excellent customer service and the most competitive prices in the diamond tool industry. The company has completed extensive research and testing, and uses the latest technologies to assure AGR Tools is at the forefront of the diamond tool industry. The company employs some of the world's top scientists, engineers and metallurgists to produce the highest quality diamond tools for the construction industry.
On October 29, 2009, AGR Tools, Inc. and AGR Stone & Tools USA, Inc. entered into a binding share exchange agreement. See AGR Tools, Inc.'s Current Report on Form 8-K filed on November 2, 2009 regarding the new share exchange agreement with AGR Stone & Tools USA, Inc. for details on various conditions which must be met before the share exchange between the two companies closes. There can be no assurance that the share exchange will close. AGR Tools, Inc must issue 46,186,516 shares of its common stock to the current shareholders of AGR Stone & Tools USA, Inc. in order to complete the share exchange. Accounting for the anticipated cancellation of 25,000,000 shares of its common stock, upon the closing of the share exchange AGR Tools, Inc. will have 81,186,516 shares of common stock issued and outstanding.
VEGA PROMOTIONAL SYSTEMS INCORPORATED (OTC: VGPR)
Detailed Quote: http://www.otcpicks.com/quotes/VGPR.php
Company Profile: http://www.otcpicks.com/Newsletter/VGPR_eProfile_110909.html
Vega Biofuels, Inc. (VGPR) was formed to pursue the production and sale of biofuel products throughout the world. With the growing need for clean energy, and the uncertain costs of fossil fuels, power generating plants around the world are looking at more useful and economical methods to run their power systems.
VGPR News:
December 18 - In A New Audio Interview at SmallCapVoice.com, Michael K. Molen, Chairman of Vega Promotional Systems, Inc., Updates Shareholders and Provides a Company Progress Report
SmallCapVoice.com, Inc. announced that a new audio interview with Vega Promotional Systems, Inc. (OTC: VGPR) is now available. The interview can be heard at http://smallcapvoice.com/blog/12-17-09-audio-interview-with-vega-promotional-systems-inc-otcpk-vgpr.
December 17 - Vega's
Vega Promotional Systems, Inc. (OTC: VGPR) recently announced the Company has entered into a Joint Venture Agreement to build multiple manufacturing plants throughout China to produce alternative energy using torrefaction technology.
The Company's Joint Venture with Global Capital Market, LTD (GCM), located in
Torrefaction is a partial carbonization process that takes place at temperatures between 475 - 575 degrees in a low temperature environment which makes the physical and energetic properties of the biomass much more comparable to traditional coal. The biomass is then compressed into briquettes to be sold to the end user. Torrefaction has the added benefit of reducing or eliminating undesirable volatiles, such as nitrous oxides and sulfur dioxides and is considered carbon neutral to the environment.
By accounting for the positive environmental impact of not allowing biomass to decay and providing a positive impact through renewable energy under an approved methodology from the Clean Development Mechanism (CDM) under the United Nations Framework Convention on Climate Change (UNFCCC), the production and sale of carbon credits from the burning of biomass for CO2 production will guarantee additional income to the Joint Venture.
The target markets for the Company's products are power plants that face mandates to increase biomass usage in their coal burning plants. Firing in existing coal plants will not require any retrofitting of existing power plants.
GCM is providing the land for the manufacturing facilities, the factories, and the necessary biomass resources to produce 100,000 metric tons of torrefaction pellets annually in each plant, generating approximately $14 million in annual revenue, per location.
Vega is currently in discussions with various funding sources to help fund the Company's participation in the project. In addition, the Company is planning a Private Placement of its securities that would include the sale of restricted stock.
Michael K. Molen, Chairman of Vega, stated, "We have had significant interest from all over the world to participate in this venture. This is a very progressive project and if we reach our goals, we will become one of the largest biomass manufacturing companies in
In addition to
LUX ENERGY CORPORATION (OTCBB: LUXED)
Detailed Quote: http://www.otcpicks.com/quotes/LUXED.php
Company Profile: http://www.otcpicks.com/lux-energy-corp/lux-energy-corp.htm
Lux Energy Corp. is an oil and gas production and exploration company focusing on developing oil and gas resources in
LUXED News:
December 16 - Lux Energy Corp Enters Into Negotiations for Participation in Significant Natural Gas Prospect
Lux Energy Corp. (OTCBB: LUXED), an oil and gas production and exploration company, announced that it has entered into negotiations to participate in significant natural gas prospect in South Eastern Alberta. Lux is seeking an agreement for a 50% working interest in eight development NG leases in the sweet gas rich areas of
The prospect will involve a drilling program of 20 to 30 wells per section drilled to depths of 800 meters. Reservoir life is estimated at between 13 to 30 years. The project has outstanding economies. Wells can be drilled, completed and tied into established gathering, processing and delivery infrastructure within 30 days. In addition, the joint venture operator advises that recent technical advances in this play have increased potential recoveries and increased production.
Shane Broesky, President of Lux Energy Corp, comments, "
Lux Energy Corp. is an oil and gas production and exploration company focusing on developing oil and gas resources in
ORDERPRO LOGISTICS INC (OTC: OPLO)
"Up 111.11% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/OPLO.php
OrderPro Logistics, Inc. is dedicated to capturing the potential of the transportation and logistics industry by employing new and innovative processes and technologies. OrderPro Logistics, Inc. can integrate every aspect of customer logistical needs from order entry through successful delivery. Customer priorities, shipment integrity, best quality, and optimization of every load is the objective of supply chain management with OrderPro Logistics, Inc. lowering costs while adding value in process and expanding service options. www.orderprologistics.com
OPLO News:
October 4 - OrderPro Logistics Executes Agreement to Purchase California Transportation Company
OrderPro Logistics, Inc. (OTC: OPLO) has announced recently that it has signed an agreement to purchase CMA Logistics, Inc., headquartered in
Jeffrey Smuda, President of OrderPro Logistics, Inc. states, "Both sides have worked hard to bring this opportunity to the table. CMA is strategically positioned for rapid growth, and our immediate efforts after closing this deal will be focused to that end."
Todd Larsen, President of CMA Logistics, Inc. states, "The strength and experience of this new team combined with our growth strategy will serve as the critical foundation for our success. We look forward to our successful union."
MILLER PETROLEUM INCORPORATED (OTCBB: MILL)
"Up 36.00% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/MILL.php
Miller Energy Resources is a high-growth oil and natural gas exploration, production and drilling company operating in multiple exploration and production projects in
MILL News:
December 16 - Miller Energy Resources Acquires More Than $300 Million Alaskan Oil and Gas Assets
* Increases Reserves by 32 times
* Acquires Proved Reserves at $0.35 per BOE
Miller Petroleum, Inc. (OTCBB: MILL), dba Miller Energy Resources ("Miller"), announced that it has acquired certain former Alaskan assets of Pacific Energy Resources ("Pacific Energy") through a Chapter 11 U.S. Bankruptcy proceeding in Delaware.
Miller has acquired total reserves of over 13.2 million barrels of oil and 15.5 BCF of natural gas, including total proved reserves of 5.6 million barrels of oil and 3.7 BCF of Natural Gas. The discounted net present value of the
In addition, Miller has acquired onshore and offshore production and processing facilities, an offshore energy platform, over 600,000 net acres of land with thousands of acres of 3-D geologic seismic data, miscellaneous roads, pads and facilities all of which originally cost almost $300 million to build and install over the last 5 years.
Miller will operate the facilities through its 100% owned subsidiary, Cook Inlet Energy LLC ("Cook") , which has been approved by the State of Alaska as the long-term operator for the Alaskan oil and gas wells. Miller has hired through Cook, the operating team who had overseen the operations of these assets from early 2000 until the present.
Acquisition Details
Miller Energy Resources paid a total of $2.25 million dollars for the Alaskan oil and gas assets, and an additional $2.22 million dollars for contract cure payments, bonds and other local, federal and State of
The
The acquisition increases Miller's total reserves 32 times, from 0.504 MMBOEs to 16.330 MMBOEs, and increases the Net Present Value (discounted at 10%) of Revenue of Miller's Oil and Gas Reserves from $4.99 million dollars (before the acquisition) to $331.13 million dollars at closing, an increase of 66 times. Miller has increased its acreage from 54,506 net acres (pre-acquisition) to 656,506 net acres at closing. Similarly, the acquisition improves Miller's Balance Sheet.
The
Also, in a related transaction, Miller issued a 6% Convertible Secured Promissory Note program ("Note") raising approximately $3 million dollars. The offering was oversubscribed. Miller utilized the proceeds from this offering to provide acquisition and working capital. The Note contains a convertible feature has the right to convert into shares of Miller's Common Stock at a 10% discount on the date of issuance.
Vulcan Capital Corporation served as advisor on this transaction for Miller. Sullivan, Hazeltine, Allinson LLC served as Bankruptcy Counsel for Miller.
Miller's Reaction to the Acquisition
This acquisition marks the third and largest acquisition by Miller since Scott M. Boruff assumed the Chief Executive position of Miller in August 2008. "The good news just keeps coming at Miller," noted Scott Boruff, "in the past year our shareholders have seen an increase of over 140% on their stock in the past year. This new acquisition should continue the strong improvement in Miller's value for our shareholders. Miller is very pleased to have been able to acquire these high-value
"The results of these acquisitions increases our reserves by 32 fold and significantly strengthens our balance sheet," commented Boruff, "Initial production is estimated to be 280 barrels of oil a day. Our three month target is over 800 barrels a day with a goal of pushing production over 1,100 barrels daily by the fourth quarter of 2010 which would generate more than $30 million dollars annually in gross revenue for Miller."
Miller's Goals
Boruff, noted the Company's immediate goals, "Our immediate focus will now be to operate these assets with an experienced team already on the ground in
Boruff acknowledged that the value of the acquisition was attractive, "The average oil company acquisition in the
"Beyond our development of our Alaska and Tennessee assets, we will also continue to be opportunistic about additional energy opportunities as they present themselves.", Boruff commented on Miller's strategy, "Miller's veteran management team has consistently been among early identifiers of premium energy assets, and has a record of repeatedly developing these assets to realize their value to shareholders' best advantage. Deal flow continues at an all time high and additional financial partners join us daily, setting the groundwork for a very exciting 2010 for Miller."
BIONOVO INCORPORATED (NASDAQ: BNVI)
"Up 21.51% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/BNVI.php
Bionovo is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, markets with significant unmet needs and billions in potential annual revenue. The company applies its expertise in the biology of menopause and cancer to design new drugs derived from botanical sources which have novel mechanisms of action. Based on the results of early and mid-stage clinical trials, Bionovo believes they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets.
BNVI News:
December 29 - Bionovo Announces Publication Describing First Novel Dual mTOR Inhibitor, BN107, for the Treatment of Breast Cancer
Bionovo, Inc. (Nasdaq: BNVI) announced the publication of results from its study on the anti-tumor mechanism of BN107. The results of the study, published in the International Journal of Cancer, describe the potential molecular mechanisms mediating the selective pro-apoptotic (cell death) effect induced by BN107 on estrogen receptor negative (ER-) breast cancer cells.
Despite favorable advances that treatment options have had on survival, oncologists continue to face challenges in providing safe and effective treatment options for ER- breast cancer patients. In this patient population, the PI3K/Akt/mTOR pathway is often abnormally activated which allows cancer cells to grow uncontrollably and evade death. There are two mTOR protein complexes, mTORC1 and mTORC2, both of which are essential for the control of aberrant survival signals. Agents that can inhibit mTORC1 and mTORC2 at the same time might lead to effective suppression of the Akt/mTOR pathway and result in tumor cell death. The study showed that BN107 decreases the levels of proteins present in the mTORC1 and mTORC2 complexes, resulting in their demise specifically in ER- breast cancer cells. The mTOR pathway as a target for cancer therapies has been actively pursued by many pharmaceutical companies. To the Company's knowledge, this is the first report demonstrating effective inhibition of both mTOR complexes concomitantly through a novel mechanism.
As explained by Dr. Sylvia Fong, Research Scientist at Bionovo, "The ability of BN107 to induce cancer cell death is selective. We demonstrate that breast cancer cells lacking estrogen receptors are highly sensitive to BN107. Our studies show that disruption of mTOR signaling mediated by both mTORC1 and mTORC2 complexes is most likely responsible for the anti-tumor effect of BN107. Simply put, BN107 has a unique way to target a specific sub-group of breast cancer cells that currently has no selective treatment. This is exciting."
"It is critical to develop novel and safe strategies to effectively treat the patients with ER- breast cancers. We believe BN107 will result in better selectivity to hormone independent tumors based on its unique selectivity and mechanisms of action. Currently the only available treatment for this group, constituting 40% of women diagnosed with breast cancer, is chemotherapy. BN107, an oral drug candidate, should provide a chronic treatment option with a low toxicity profile," said Dr. Isaac Cohen, Chairman and CEO of Bionovo.
ASPENBIO PHARMA INCORPORATED (NASDAQ: APPY)
"Up 26.28% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/APPY.php
AspenBio Pharma is an emerging bio-pharmaceutical company dedicated to the discovery; development, manufacture, and marketing of novel proprietary products, including those that enhance the reproductive efficiency of animals and that have large worldwide market potential. The company was originally formed to produce purified proteins for diagnostic applications and has successfully leveraged this foundational science and technology expertise to rapidly develop an enviable late-stage pipeline of several novel reproduction hormone analogs for wide-ranging therapeutic use initially in bovine and equine species. AspenBio Pharma continues to advance the development and testing of its three first-generation blood-based human diagnostic tests designed as an aid in the diagnosis of human appendicitis.
APPY News:
December 29 - AspenBio Pharma Reports Progress on the Supplemental Clinical Trial, Work to Improve the Clinical Utility of AppyScore™ and Scheduled Meeting With FDA
Company Initiates Interim Trial Data Analysis; January Meeting With FDA
AspenBio Pharma, Inc. (Nasdaq: APPY), an emerging bio-science company dedicated to the development of novel diagnostics and drugs for humans and animals, reported on its progress and plans for the Premarket Notification 510(k) submission of its ELISA format AppyScore™ test. AppyScore is the first blood-based test designed to aid in the evaluation of patients suspected of having acute appendicitis.
The previously announced AppyScore supplemental clinical trial continues to advance, with over 400 patients enrolled to-date from the emergency departments of more than a dozen well-known hospitals across the
Applying the parameters of this SAP in a retrospective analysis of the previous pivotal clinical trial data improved the negative predictive value ("NPV") of AppyScore to more than 95% in the subset of patients who have negative results for either the combination of AppyScore/WBC or AppyScore/neutrophil count. While there can be no absolute assurance that these results will be repeated in the current supplemental clinical trial, the company believes such results, if repeated would substantially enhance the clinical utility and value of AppyScore in the emergency department setting.
The SAP provides for, and AspenBio has scheduled, an interim analysis of the clinical trial data to validate the required supplemental trial sample size necessary to achieve statistical significance for all study endpoints. Achieving statistical significance is essential for the inclusion of these important study end points in the submission of the Premarket Notification 510(k) information to the FDA, as well as describing clinical utility to physicians. This interim analysis was initially planned to be conducted with data from 250 patients; however, with the addition of the two new alternative study end points, a 400 patient interim data analysis will provide better predictive results of the final sample size needed. While patient recruitment continues uninterrupted, the interim analysis will be conducted in the upcoming weeks and is expected to be completed by late January or early February 2010. This analysis may demonstrate that the previously planned trial size is sufficient, or it may indicate a need to expand the size in order to achieve statistical significance of all end points. If an expansion of the trial is determined to be necessary, the timing for advancing the Premarket Notification 510(k) through the FDA will be evaluated and adjusted to ensure that the quality of the trial is not compromised and the clinical and statistical results are sound and compelling.
In recent weeks a panel of clinical experts was convened to evaluate AppyScore's clinical utility and offer an independent opinion about its usefulness. Considering the currently available diagnostic modalities for appendicitis, the panel identified a strong need for better diagnostic tools to help identify a group of patients that is at low risk of having acute appendicitis. For this low-risk group, the panel indicated that a test with NPVs as high as those seen in the previous trial data when analyzed using the combination AppyScore/WBC or AppyScore/neutrophil count would provide compelling clinical evidence for the test to be widely used in evaluating patients suspected of having acute appendicitis. This panel also prepared a consensus paper expressing their opinion about the expected use of AppyScore in clinical practice. The clinical and regulatory direction the company is currently pursuing is in line with the opinions expressed in this paper.
AppyScore is anticipated to be used as a diagnostic tool to aid emergency department physicians in identifying a subset of patients for whom the risk of acute appendicitis is sufficiently low to support consideration for delaying or eliminating the need for computed tomography (commonly known as a CAT scan) and/or immediate surgical consultation.
To address the 510(k) and related matters, the company has scheduled a meeting with the FDA in January 2010. One of the objectives of the meeting is to ensure alignment with the FDA with respect to the data requirements necessary to support the proposed intended use and clinical utility of the AppyScore test.
Following the meeting with the FDA and the completion of the interim data analysis, the company expects to be in a position to provide a further update to shareholders regarding the supplemental clinical trial patient size and plans for advancing 510(k) clearance.
Dr. Robert Caspari, COO and CMO of AspenBio, commented: "We have received a clear message from our outside clinical experts, which is supported by our Medical Advisory Board, that the clinical value of AppyScore will be significantly enhanced by data that demonstrate that AppyScore achieves a negative predictive value substantially higher than current diagnostic modalities when used in conjunction with other commonly ordered diagnostic tests. We believe that taking the steps necessary to accomplish this objective will be well worth the time and costs and will result in added value."
While the ELISA-based supplemental AppyScore trial has been preceding, AspenBio has also been advancing the development of its new stand alone, state-of-the-art cassette and reader instrument platform that provides AppyScore results more rapidly and efficiently than the ELISA format. This platform offers many benefits over an ELISA-based test. It can produce results in approximately 15 minutes, which in turn can be rapidly and accurately uploaded to a hospital's Laboratory Information System ("LIS") via a built-in electronic interface. More importantly, as a fully integrated, stand alone assay system, it can significantly reduce an operator's processing steps and the corresponding potential for errors.
Clinical trials of the rapid assay are planned for 2010 and will be designed to support a 510(k) submission for this rapid assay platform using the ELISA test as a predicate, assuming the ELISA test is cleared by the FDA. In addition, these trials will provide AspenBio and physicians with additional information on the product's potential utility. The company expects to announce the execution of supply agreements with internationally recognized manufacturers for the rapid assay device and reader instrument as they are finalized.
MOBILE MEDIA UNLIMITED HOLDINGS INCORPORATED (OTC: MMUH)
"Up 25.00% in morning trading"
Detailed Quote: http://www.otcpicks.com/quotes/MMUH.php
MMU is a leader in mobile marketing technologies, utilizing proprietary state-of-the-art marketing solutions and our unique ability to reach millions of new consumers simultaneously. With our extensive "opt in" inventory, MMU strives to stay ahead of the curve, giving our clients a seamless delivery solution and the highest quality of customer service.
MMUH News:
December 28 - MMU Holdings Inc. Definitive Agreement Executed With TzuFuma Inc.
Mobile Media Unlimited Holdings Inc. (OTC: MMUH) announced that the Company has executed the Definitive Agreement ("DA") with TzuFuma Inc. MMUH will purchase TzuFuma in an all stock transaction costing MMUH 58,000,000 shares of newly issued restricted common stock.
TzuFuma Inc. is a wholesale distributor business of Electronic Cigarettes. Electronic Cigarettes or E-Cigarettes are technological marvels which have the look, taste and feel of a real cigarette without any combustible components and produces water vapor instead of second-hand smoke. The advantages of this product are apparent since no actual smoke by-product is created, and users have the freedom to enjoy smoking in establishments currently smoker unfriendly.
Robert Paterson, President of TzuFuma Inc. stated in a telephone interview: "We have ironed out all of the remaining details regarding financing and the integration of the acquisition and I am pleased to announce that no significant material changes were made to the original MOI. The Company and its associates bring a wide talent pool to the table with skill sets we believe will immediately enhance marketing and accelerate our clients into mass distribution here in the United States but more importantly Internationally. We anticipate gross revenues from domestic sales to be in the region of 12-14% of our total gross revenue for fiscal 2010. We fully anticipate 2010 to be a bumper year."
LA JOLLA PHARMACEUTICAL COMPANY (NASDAQ: LJPC)
"Up 17.21% in morning trading"
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 22 - La Jolla Pharmaceutical Company Announces Filing of Joint Proxy Statement/Prospectus
La Jolla Pharmaceutical Company (Nasdaq: LJPC) (“La Jolla”) announced that it has filed its Registration Statement on Form S-4 with the Securities and Exchange Commission (“SEC”) in connection with its proposed merger with Adamis Pharmaceuticals Corporation (“Adamis”). The definitive merger agreement was entered into on December 4, 2009 and closing of the merger is subject to certain closing conditions, including approval by the stockholders of
The Registration Statement contains detailed information regarding the merger, including answers to the following frequently asked questions:
Q: What is the transaction?
A: The transaction is the merger of La Jolla’s wholly-owned subsidiary, Jewel Merger Sub, Inc., with and into Adamis, with Adamis surviving the merger as a wholly-owned subsidiary of
Q: Why are the two companies proposing to merge?
A: The combined company resulting from the merger will be a specialty pharmaceutical company that has recently launched its first significant product, has several product candidates in late stage development and will be led by an experienced senior management team from Adamis. The merger provides La Jolla with a product pipeline and provides Adamis with the anticipated net cash from
Q: What is the reverse stock split and why is it necessary?
A: The reverse stock split is the combination of the outstanding shares of
The reverse stock split only affects the La Jolla stockholders and is necessary to adjust the number of shares owned by La Jolla stockholders so that they represent an agreed-upon percentage of the combined company, after giving effect to the fair value of the net assets that
Q: How is the reverse stock split calculated?
A: The precise reverse stock split ratio will be determined based on the amount of La Jolla’s net cash as of the closing date of the merger, plus $750,000, divided by Adamis’ weighted average stock price prior to closing, 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 estimated percentage ownership of the outstanding shares of common stock of the combined company that Adamis stockholders and current La Jolla stockholders would be expected to hold immediately following the closing of the merger, based on an assumed 45,972,303 outstanding Adamis shares and 65,722,648 outstanding La Jolla shares at the closing date of the merger, and reflecting the assumed high and low amounts of La Jolla Net Cash ($3.0 million (high) and $2.5 million (low), respectively) and different Adamis weighted average stock prices and related discounted stock prices.
Q: How many shares of common stock of the combined company would I own assuming that I currently own 100 shares of
A: As a result of the proposed reverse stock split, immediately prior to the effective time of the merger, your 100 shares of La Jolla common stock would be reduced to a range expected to be between 3 and 33 shares of common stock of the combined company (depending on the reverse split ratio, which is expected to range between one-for-three and one-for-thirty). After your shares are subject to this reverse stock split, La Jolla will then issue new post-reverse split shares of La Jolla common stock to holders of Adamis common stock on a fixed one-for-one basis in connection with the merger.
Q: How many shares of common stock of the combined company would I own assuming that I currently own 100 shares of Adamis common stock?
A: As a result of the merger, immediately after the effective time of the merger, your 100 shares of Adamis common stock will be converted into 100 shares of
Q: What will happen to any options or warrants to acquire Adamis common stock in the merger?
A: In connection with the merger, Adamis warrant holders and option holders will have their Adamis warrants and options converted into warrants and options to purchase
Q: Who will be the directors and executive officers of the combined company immediately following the merger?
A: Immediately following the merger, the board of directors of the combined company is expected to be composed solely of the members of the Adamis board of directors prior to the merger: Dennis J. Carlo, Ph.D., David J. Marguglio and Richard L. Aloi. Immediately following the merger, the executive management team of the combined company is expected to be composed solely of the members of the Adamis executive management team prior to the merger:
Q: What happens to
A: La Jolla will have limited cash resources, and if the merger with Adamis does not close, the La Jolla board of directors may elect to, among other things, attempt to complete another strategic transaction or wind down the business in a voluntary dissolution under Delaware law.
Q: When do
A:
Other Information
NASDAQ has informed La Jolla that the merger will constitute a change of control, which will require that
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