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ILNS Intellect Neurosciences Files New Patent Applications for Immunotherapy Methods to Target Abnormal Tau Protein in Treatment of Alzheimer's disease
http://finance.yahoo.com/news/Intellect-Neurosciences-Files-prnews-13479710.html?x=0
ILNS Form 10-Q INTELLECT NEUROSCIENCES, INC.
http://biz.yahoo.com/e/120202/ilns.pk10-q.html
ILNS Intellect Neurosciences Issues Letter to Shareholders
NEW YORK, Feb. 2, 2012 /PRNewswire/ -- Intellect Neurosciences, Inc. (OTCBB:ILNS.PK - News), a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment of Alzheimer's and other neurological diseases today issued the following Letter to Shareholders from Dr. Daniel Chain, Chairman and CEO.
(Logo: http://photos.prnewswire.com/prnh/20111214/NY22484LOGO )
Dear Shareholder,
2011 was an exceptionally fruitful year for Intellect Neurosciences. We introduced two new innovative platform technologies, which will set the stage for the future direction of the company and offer significant potential to create value for the Company and our shareholders. We also ended the year with an improved balance sheet. As we enter 2012, we are excited by the prospect that our pioneering Alzheimer's disease immunotherapy ANTISENILIN® technology may be validated in the Phase 3 trials for Bapineuzumab, which are nearing completion. In addition, we expect to demonstrate proof-of-concept in our early stage programs: IN-N01-OX2, a compound of CONJUMAB-A, our antibody drug conjugate platform; and RV03, a compound of RECALL-VAX, and the first dual-acting Alzheimer's disease vaccine targeting both beta amyloid and tau proteins.
Of particular significance and importance to Intellect Neurosciences in 2011, we completed a transaction with ViroPharma for our OX1 program. ViroPharma is one of the leading biotechnology companies, and they have done a stellar job of capturing the majority of market share in an orphan indication. Commensurate with the transaction, we received an upfront payment of $6.5 million, and we have the potential to receive up to $120 million in regulatory milestone payments, in addition to a two-tiered royalty reaching double digits from future potential drug sales. ViroPharma will bear all of the costs of continued development and commercialization. Mr. Vincent Milano, ViroPharma's CEO, spoke enthusiastically about his company's plans to develop OX1 for Friedreich's Ataxia during his presentation at the JP Morgan Healthcare Conference in January 2012, indicating OX1 likely would enter Phase 2 clinical trials early in 2013. Mr. Milano expressed hope that OX1 would be at least as successful as ViroPharma's best-selling orphan drug, CINRYZE®, which reportedly generated more than $300 million in sales revenue last year. We could not be more pleased that ViroPharma chose Intellect Neurosciences' product for its next development program.
To ensure an ongoing pipeline of product candidates that have the potential to build shareholder value, we focused on developing other assets in our pipeline and further enriching our patent estate. We filed patent applications at the United States Patent and Trademark Office (USPTO) based on two new discoveries, which we believe will result in important next generation biologics for the treatment of Alzheimer's and other neurodegenerative diseases. Already we have received positive feedback from major pharmaceutical companies interested in specific drug products of these platform technologies. Discussions are commencing with potential partners, even at this early stage.
Pipeline Activities:
We introduced RV03 during 2011, a first-in-class Alzheimer's vaccine candidate, which targets the two proteins that are the hallmark features of the disease: beta amyloid, which accumulates in the brains of Alzheimer's patients and deposits as plaques on the surface of nerve cells, and abnormal tau proteins, which comprise intracellular neurofibrillary tangles. Although both beta amyloid and tau have been studied extensively on an individual basis with regard to their separate modes of toxicity, new light has been shed recently on their possible interactions and synergistic effects in Alzheimer's disease. Independent published studies have shifted our understanding of the role of tau in the pathogenesis of Alzheimer's disease towards being a crucial partner of beta amyloid. Of particular interest is the cleavage of tau protein by "executioner" caspases, which leads to a truncated form of the protein that is more toxic than the intact protein and can precede tangle formation.
It occurred to us that we could use our RECALL-VAX platform to generate an immune response specifically targeting this more toxic form of tau, known as delta tau. Moreover, since RECALL-VAX technology lends itself particularly well to a combined vaccine, we are using it to target both beta amyloid and delta tau, in each case taking advantage of the unique molecular signatures ("neoepitopes") formed by the cleavage of the precursor proteins. We are in the process of embarking on proof-of-concept studies for RV03 in a transgenic mouse model of Alzheimer's disease, which expresses both human beta amyloid and delta tau. We expect initial data by the end of 2012.
CONJUMAB-A is our novel proprietary antibody-empowering platform technology that we believe has the potential to yield a new class of improved therapeutics and diagnostics for treatment of Alzheimer's disease and other proteinopathies. The technology is based on antibody-drug conjugates (ADCs) that specifically target amyloid and amyloid-associated proteins, as well as associated toxicity, such as oxidative stress and inflammation leading to tissue damage. CONJUMAB-A is the first application of ADCs to treatment of neurodegenerative diseases and aims to capitalize on the significant advances made with ADCs in the field of oncology. CONJUMAB-A has the potential to improve on current methods of passive immunotherapy by increasing clearance of amyloid or amyloid-associated proteins while delivering potent cytoprotective molecules to sites of amyloidosis, and thus, reduce inflammation and oxidative stress.
CONJUMAB-A has potential application for treatment of several serious diseases, such as Alzheimer's, Parkinson's, Huntington's, Cerebral Amyloid Angiopathy, Frontotemporal Dementia, Progressive Supranuclear Palsy, Pick's disease, Creutzfeldt-Jakob disease and Cortical Basal Degeneration. It also may be effective in non-CNS indications, such as Age-Related Macular Degeneration, Glaucoma, and Peripheral Amyloidosis.
Intellect Neuroscience's lead CONJUMAB-A candidate is IN-N01-OX2, a non-activating, stabilized IgG4 humanized monoclonal antibody specific for beta amyloid protein conjugated to OX2, a small molecule with potent neuroprotective properties due to its dual activities as an anti-oxidant and protein aggregation inhibitor. We are developing IN-N01-OX2 as first-in-class treatment for retinal degeneration, notably age-related macular degeneration and glaucoma. The drug candidate also has potential applications for Alzheimer's disease and traumatic brain injury.
CONJUMAB-A offers us multiple opportunities for commercialization: For example, we may partner products developed internally by Intellect (e.g. IN-N01-OX2). Alternatively, we can license use of the technology to other companies that have different antibodies that would be suitable for development as new antibody drug conjugates in combination with OX2 or other small molecule. We may also partner with companies that have other neuroprotective small molecules for use in an antibody drug conjugate.
R&D Team:
Continuing with our operational goals to maintain a streamlined, effective team to manage our international virtual R&D activities, we have made two recent additions: Dr. Vadim Fedulov, Ph.D., an expert in transgenic mouse models of neurodegeneration, based in Copenhagen, Denmark, serves as Project Manager and Dr. Dan Shochat, Ph.D., based in San Francisco, serves as Consulting Vice President Non-Clinical Development.
Dr. Shochat is a pioneer in the antibody development field with more than 20 years of experience in the biotechnology industry. He has been instrumental in the invention and development of the approved in vivo tumor-imaging reagent CEA-Scan™ and led the team that obtained the first approved antibody-drug conjugate, Mylotarg™. He was pivotal to the development of Bexxar™, a radioiodinated antibody for the treatment of Non-Hodgkin's Lymphoma that was approved by the FDA in June 2003. In 2001 he joined Deltagen as Vice President of Pharmaceutical Development and in 2003 co-founded Celscia Therapeutics Inc., a therapeutic antibodies development company, which merged with KaloBios Therapeutics in January 2004 where he has held the position of Executive Vice President, Development.
Patent News:
We continue to devote considerable resources to our patent estate, including ongoing patent prosecution, defending existing patents and adding new patent applications to revitalize our patent portfolio. Of particular significance, we obtained a new patent in both the United States and Japan for our RECALL-VAX technology platform in 2011. In Europe, we filed an appeal in response to an opposition filed against us by Wyeth and Élan Pharmaceuticals with respect to our ANTISENILIN® patent estate. We remain confident of our ability to prevail in this process. In addition, we have additional divisional applications pending to further protect us. We obtained strong support for our patent prosecution in Europe and the U.S. from world-renown independent experts who provided written declarations explaining errors in the office actions against us. This support gives us good reason to believe we ultimately will be granted the patents we are seeking.
Current Period Financial Summary:
As of December 31, 2011, we had cash and cash equivalents of $1,053,880. Proceeds from the ViroPharma transaction were used to pay expenses related to the transaction, including payment of $1.3 million in licensing fees to our university research partners; $826,000 to consultants who helped secure the agreement; legal fees incurred in connection with executing the transaction; and payment of significant overdue accounts payable owed to contract research organizations, independent auditors, former independent directors and other vendors. The balance has been set aside for working capital.
Operating expenses for the three months ended December 31, 2011, increased by $3,173,825, to $3,924,828 from $751,003 for the comparable period last year. The increase in operating expenses was caused by an increase in both General and Administrative expenses primarily related to the ViroPharma transaction and an increase in Research and Development fees.
Other income (expenses) for the three months ended December 31, 2011, changed by $19,324,458, to income of $17,933,750 from a loss of $1,390,708 for the comparable period last year. The change primarily was due to a non-cash gain on the change in the value of derivative instruments and preferred stock liability and a reduction in interest expense.
Increased public awareness:
We have continued our efforts to increase public and investor awareness of Intellect Neurosciences through media outreach and other activities, including speaking at several international industry and investor conferences. Our activities and developments are frequently reported in the media, including several articles that have appeared in BioCentury, a professional online magazine that is read widely in the industry. These activities have contributed to the increased attention we have received from potential strategic partners. We will continue these activities in 2012.
2011 was a year of remarkable achievements for a company with the small size and limited resources of Intellect. These achievements have yielded our current licenses and rich pipeline that generates continued interest from major biotechnology and pharmaceutical companies.
Thank you for your continued support of Intellect Neurosciences and our important mission to create a world without Alzheimer's disease and other horrifying neurodegenerative diseases.
Sincerely,
Daniel G. Chain, PhD
Chairman & CEO
Safe Harbor Statement Regarding Forward-Looking Statements:
The statements in this release and oral statements made by representatives of Intellect relating to matters that are not historical facts (including, without limitation, those regarding future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Intellect's product candidates and the sufficiency of Intellect's cash and other capital resources) are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that actual performance or results could materially differ, that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, or Intellect's ability to fund such efforts with or without partners. Intellect undertakes no obligation to update any of these statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly, any forward-looking statements should be read in conjunction with the additional risks and uncertainties detailed in Intellect's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in Intellect's Annual Report on Form 10-K (file no. 333-128226), filed on October 13, 2011, and in our Quarterly Report on Form 10-Q for the quarterly period ended December 31, 2011, filed on February 2, 2012.
Contact:
Jules Abraham
JQA Partners, LLC
917-885-7378
Jabraham@jqapartners.com
btw, deleted posts about MLXO are retrievable.
Technology is beautiful.
re: MLXO, a member's post: Wait....we're trading Deano for Elcheepo? Seriously? Nothing against elcheepo but I just always took his negative outlook on life and MLXO as humor. Now he/she's a moderator"?
RE: MLXO. Monkey see, Monkey do.
In other words, peeps watching MLXO buying may also buy, lol.
Hope the fox doesn't get the possum in MLXO
while the share price is rising.
MLXO shareholders are supporting themselves
but management, vice versa.
MLXO chart improvement in 2012.
5 day avg. crossed up and over 10 avg.
MLXO communication better kept private,
just like Michelex management CEO Sabir Saleem.
MSLP.OB MusclePharm Inks Deal With NFL Superstar, 49er All-Pro Patrick Willis
PR Newswire
DENVER, Jan. 12, 2012 /PRNewswire/ -- MusclePharm Corporation, a Nevada corporation ("MusclePharm" or the "Company") (OTCBB: MSLP.OB - News), an expanding U.S. nutritional supplement company, is pleased to announce that it has signed San Francisco 49er superstar linebacker Patrick Willis.
The NFL standout has been a perennial All-Pro selection and is also a five-time Pro Bowl selection.
A two-time All-American at Mississippi, the first-round draft pick of the 49ers in 2007 has quickly become one of the top defensive players in the NFL.
In fact, an ESPN.com expert vote, Willis was named the NFL's best linebacker and the fourth-best defensive player.
In addition to his tremendous on-field success, Willis' rigorous fitness regimen and noted work ethic also makes him an ideal match with MusclePharm and its healthy lifestyle vision.
Willis' social media following includes nearly 105,000 fans on Twitter as well, which fits in perfectly with MusclePharm's impressive and strong social media presence.
"I love the fact that I can partner with a company that is developing cutting edge products that help me train harder and perform to the best of my abilities," NFL Superstar Patrick Willis said. "MusclePharm takes the guess work out of using supplements because I know they take the time to test all their products above and beyond what is required for athletes. MusclePharm is the Athletes Company and I am excited to join the team."
MusclePharm, which is the official nutritional supplement provider of the Ultimate Fighting Championship (UFC), has also inked deals with NFL superstars Michael Vick and Chad Ochocinco in 2011.
MusclePharm continues to grow at an impressive rate as well, setting a monthly company sales record ($2,700,000) in November.
http://finance.yahoo.com/news/MusclePharm-Inks-Deal-With-prnews-3982603325.html?x=0
GNVC - Law Firm Brower Piven Announces Investigation of Investor Securities Fraud Against GenVec, Inc.
STEVENSON, Md.--(BUSINESS WIRE)-- The law firm of Brower Piven, A Professional Corporation, is investigating potential securities fraud claims against GenVec, Inc. (“GenVec”) (NASDAQ: GNVC - News) regarding whether GenVec may have issued materially false or misleading information to investors before announcing on March 29, 2011 that it was discontinuing its Phase III clinical trial of TNFerade in patients with locally advanced pancreatic cancer.
Brower Piven has been retained to commence a securities class action lawsuit on behalf of GenVec investors to recover investment losses. If you purchased or acquired GenVec securities between March 12, 2009 and March 29, 2010 and have suffered a loss on your investment, or if you believe you have information relating to the subject matter of our investigation, you may email or call Brower Piven, who will, without obligation or cost to you, attempt to answer your questions. You may contact Brower Piven by email at hoffman@browerpiven.com, by calling 410/415-6616, or by writing to Brower Piven, A Professional Corporation, 1925 Old Valley Road, Stevenson, Maryland 21153. Attorneys at Brower Piven have combined experience litigating securities and other class action cases of over 60 years.
Contact:
Brower Piven, A Professional Corporation
Stevenson, Maryland
Charles J. Piven, 410-415-6616
hoffman@browerpiven.com
http://finance.yahoo.com/news/Law-Firm-Brower-Piven-bw-642692649.html?x=0
Merry Xmas $b_rich$, et al.
Most charts of stock ideas appear unfavorable.
KBLB (.083) CMF about to turn positive.
GNBT PR today: Generex Biotech and Avanir Pharmaceuticals Look to Rally in 2012
The Paragon Report Provides Equity Research on Generex Biotechnology & Avanir Pharmaceuticals
NEW YORK, NY, Dec 12, 2011 (MARKETWIRE via COMTEX) -- The biotechnology industry has been a strong performer in 2011 as mergers and acquisitions and favorable legislation have propped up the sector. The domestic biotechnology industry has tapped into only a fraction of its several potential applications and is expected to grow to $146.2 billion in 2016, from an estimated $92.4 billion in 2011, according to a report from IBISWorld. The Paragon Report examines investing opportunities in the Biotechnology Industry and provides equity research on Generex Biotechnology Corporation GNBT -6.38% and Avanir Pharmaceuticals, Inc. AVNR -5.22% . Access to the full company reports can be found at:
www.paragonreport.com/GNBT
www.paragonreport.com/AVNR
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. Last month the company announced that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application for NUEDEXTA for the treatment of pseudobulbar affect (PBA).
NUEDEXTA was approved by the U.S. Food and Drug Administration in October 2010 for the treatment of PBA, a neurologic condition which is characterized by frequent outbursts of involuntary crying or laughing.
The Paragon Report provides investors with an excellent first step in their due diligence by providing daily trading ideas, and consolidating the public information available on them. For more investment research on the biotechnology industry register with us free at www.paragonreport.com and get exclusive access to our numerous stock reports and industry newsletters.
Generex Biotechnology Corporation is a development stage company engaged in the research and development of drug delivery systems and technologies for metabolic and immunological diseases. Last week shares of the company spiked after it announced that positive interim Phase 2 clinical data from its ongoing study of a novel Ii-Key Hybrid-based HER-2/neu Peptide Vaccine (AE37) in HER-2 expressing breast cancer patients were presented at the 34th Annual CTRC-AACR.
Generex explains that its Ii-Key Hybrid technology platform entails the modification of fragments of antigens to increase their potency in stimulating critical members of the immune response, known as CD4+ T helper cells.
The Paragon Report has not been compensated by any of the above-mentioned publicly traded companies. Paragon Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at http://www.paragonreport.com/disclaimer
SOURCE: Paragon Financial Limited
http://www.marketwatch.com/story/generex-biotech-and-avanir-pharmaceuticals-look-to-rally-in-2012-2011-12-12
GNBT - PR: 12/8/11 Breast Cancer Vaccine Reduces Cancer Recurrence in Women: Interim Results From Phase 2 Clinical Trial Trend Toward AE37 Vaccine Benefit; Results Presented at SABCS
Positive Top-line Interim Results from Phase 2 Study of AE37 presented this week: Final Phase 2 Results Expected in 2012
WORCESTER, Mass. and TORONTO, Dec. 8, 2011 /PRNewswire/ -- Generex Biotechnology Corporation (OTCBB: GNBT.OB) today announced that positive interim Phase 2 clinical data from its ongoing study of a novel Ii-Key Hybrid-based HER-2/neu Peptide Vaccine (AE37) in HER-2 expressing breast cancer patients were presented at the 34th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas. The AE37 vaccine is being developed by its wholly-owned subsidiary, Antigen Express, Inc.
(Logo: http://photos.prnewswire.com/prnh/20110106/NY25057LOGO-b)
"We are encouraged by the positive interim results in disease-free survival demonstrated in the randomized Phase 2 study with AE37 vaccine, especially in patients with low HER2 expression that are not currently eligible for Herceptin® (trastuzumab; Roche-Genentech)," said Dr. Eric von Hofe, Ph.D., President of Antigen Express. "While the number of patients with recurrent breast cancer is still too low to demonstrate statistical significance in this ongoing study, we project a sufficient number of events in 2012 and expect to report final results during this period."
The results were presented at SABC by COL George E. Peoples, MD's Cancer Vaccine Development Program on December 7 th. "Women with breast cancers expressing low levels of HER2 do not benefit from targeted HER2 therapies that are currently available," said COL Peoples, a leading researcher in adjuvant breast cancer vaccine development. "Our research is focused on reducing the recurrence of cancer using a woman's own immune system to fight her disease, including breast cancers that express low levels of HER2. The AE37 vaccine is based on over 5 years of research and continues to show promise in a well-designed and ongoing randomized Phase 2 clinical trial that if positive, will allow rapid transition to Phase 3."
AE37 is the subject of an ongoing, controlled, randomized, and single-blinded Phase 2 clinical study in human epidermal growth factor receptor 2 (HER2) expressing patients with either node positive or high-risk node-negative breast cancer. Patients are randomized to receive AE37 plus granulocyte-macrophage colony-stimulating factor (GM-CSF) or GM-CSF alone (control). The primary endpoint is a reduction in cancer relapse after two years.
There are currently over 250 patients enrolled in the Phase 2 study. Kaplan-Meier projections of updated data presented at SABCS ("An Update of a Phase II Trial of the HER2 Peptide AE37 Vaccine in Breast Cancer Patients to Prevent Recurrence," abstract #PT1-13-01) demonstrate that disease-free survival in the low HER2 expressing patients was 88.6% in the treated group (n=53) versus 71.9% in the control arm (n=78) at a median follow-up of 22 months.
Patients treated with vaccine also exhibited a statistically significant increase in positive immune reactions to a test dose of HER2 (AE36 (HER2:776-790)) protein including maintenance of positive immune response up to 12 months post-vaccination while there have been no changes in immune responses for control patients.
The Company is assessing the data for potential opportunity to move forward with a Phase 3 clinical development program following an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for AE37, which Antigen Express believes, if confirmed, could occur in the first half of 2012.
About AE37 and Ii-Key Hybrid Platform Technology
Antigen Express is a platform technology and product-based company developing proprietary vaccine formulations for large, unmet medical needs. The Company's Ii-Key Hybrid technology platform entails the modification of fragments of antigens to increase their potency in stimulating critical members of the immune response, known as CD4+ T helper cells. Incorporating the Ii-Key modification along with tumor-associated antigens can greatly enhance the immune system's ability to recognize and destroy cancer cells bearing any of the targeted antigens as well as increasing immunological memory.
The first product candidate utilizing the Company's novel Ii-Key Hybrid technology platform is a HER-2/neu Peptide Vaccine (AE37). This "off-the-shelf" cancer immunotherapy product candidate is easier and less costly to produce than comparable cell-based approaches. AE37 is derived from a peptide fragment of the human epidermal growth factor receptor 2 (HER2) oncoprotein, which is expressed in a variety of tumors including 75-80% of breast cancers as well as a high percentage of prostate, ovarian and other cancers. AE37 represents the only HER2-based peptide vaccine currently being studied in a randomized trial and its use is not restricted to patients with a particular type of human leukocyte antigen (HLA) peptide.
About Breast Cancer
According to the American Cancer Society, more than 232,000 women will be diagnosed with breast cancer, and nearly 40,000 will die from the disease, in 2011. For women whose cancer tests positive for increased quantities of the HER2, approved targeted therapies include trastuzumab (Herceptin®; Roche-Genentech). However, only 25% of breast cancer patients have HER2 levels high enough to be eligible for Herceptin. AE37 is positioned initially as an adjuvant therapy for at least 50% of breast cancer patients; i.e., those with low-to-intermediate levels of HER2 expression.
About Generex Biotechnology Corporation
Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist™ device. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T-helper stimulation in immunotherapy. One of its platform technologies relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T-helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
Cautionary Note Regarding Forward-Looking Statements
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
SOURCE Generex Biotechnology Corporation
CONTACT: CONTACT: Investor Relations: Generex Biotechnology Corporation, Todd Falls,
1-800-391-6755
Seahawk Capital Partners, Inc., Joseph Moscato,
+1-646-599-6222
Web Site: http://www.generex.com
Link to above article: http://www.drugs.com/clinical_trials/breast-cancer-vaccine-reduces-cancer-recurrence-women-interim-results-phase-2-clinical-trial-trend-12783.html
KBLB Kraig Biocraft Laboratories Announces Creation of Seven New Strains of Transgenic Silkworms Using Zinc Finger Nuclease Technology
New Development Seen as a Major Leap in the Creation of Next Generation Spider Silk Technology
Kraig Biocraft Laboratories, Inc. announced that researchers at the University of Notre Dame, utilizing customized zinc finger configurations licensed to Kraig from Sigma-Aldrich, succeeded in creating seven or more strains of transgenically modified silkworms.
The Company believes that this breakthrough removes the largest barrier to pure spider silk technology.
The zinc finger nuclease were designed to cleave the silkworm's native heavy chain gene. The resulting silkworms were inter-mated to produce 50 mating pairs, which each produced clutches of approximately 100 eggs. Genetic testing designed to detect mutations at the site of zinc finger cleavage were preformed and the testing recovered positive results for zinc finger disruption, therefore knockout of the native heavy chain gene in embryos, from 7 of the first 13 mating pairs, analyzed.
"This success rate is much higher than we ever expected," said Company CEO and founder Kim Thompson. "The laboratory reports that seven new strains of transgenics have been confirmed so far."
"The bottom line is that zinc finger nuclease works exceedingly well for our particular targets. Our adopting this technology was a bit of a gamble at the time, but it turns out to have been one of the smartest moves we could have made. We view this genetic knockout as the achievement of our greatest scientific goal for 2011," continued Thompson.
Dr. Malcolm Fraser reported, "We anticipate that we will be able to recover homozygous knockout silkworms from these pools of embryos with little difficulty. These homozygous commercial strain heavy chain knockouts will serve as a more effective platform technology for rapid development and commercialization of future spider silk transgenics, allowing us to readily recover commercially ready spider silk transgenics by simply screening for the production of cocoons."
Dr. Fraser concluded, "This Zinc Finger approach exceeded our best expectations in terms of its capabilities for introducing mutations in silkworms. The frequency of mutation events and the capability of working directly with the commercial strains give a much more rapid route to new, commercially relevant transgenics."
The Company believes that the next generation of its technology, which utilizes zinc fingers, will significantly expand its product capabilities and target markets.
Thompson further stated, "Dr. Fraser and his team have once again verified our scientific models. The results also serve as proof of efficacy for the creation of targeted transgenics, and confirm our confidence in the power of zinc finger technologies. We now believe that we have both the platform and targeted transgenic capabilities which we need to create Generation II and Generation III technical textiles."
The Company is already ramping up production of Monster Silk, its previously disclosed product which is the subject of the Company's recent licensing agreement with the University of Notre Dame. While Monster Silk is targeted for conventional applications, the Company believes that the technology described in today's announcement will ultimately unlock applications for technical textiles and broader markets.
GenVec to Release Third Quarter 2011 Financial Results and Conduct a Conference Call on November 9, 2011
GenVec, Inc. (Nasdaq:GNVC - News) will report financial results for the third quarter of 2011 on Wednesday, November 9, 2011, before the U.S. financial markets open. The announcement will be followed by a webcast and conference call at 10:00 a.m. EST to discuss the company's third quarter financial results and business outlook.
To listen to the live conference call, please dial 877-558-0567 (U.S. or Canada) or 706-643-4980 (international) and use the following Conference ID: 23292607. An audio replay of the conference call will be available starting at 1:00 p.m. EST on November 9, 2011 through November 16, 2011. To listen to the audio replay, dial 855-859-2056 or 404-537-3406 and use Conference Replay ID: 23292607.
To access the webcast or the replay, go to www.genvec.com, click on "Investors and Media," and click on "Events and Presentations."
Kraig Biocraft Laboratories, Inc. Signs Spider Silk Commercial License Agreement With the University of Notre Dame
Kraig Biocraft Laboratories, Inc. KBLB.PK - News) (the "Company" or "Kraig") announced that it signed a commercial license agreement with the University of Notre Dame regarding spider silk technologies.
The agreement awards Kraig the exclusive worldwide commercial rights to certain spider silk technologies which the Company jointly developed with the University of Notre Dame. Pursuant to the agreement, the University of Notre Dame will become a shareholder of the Company. The University will also receive a 2% royalty of the Company's net sales of products which incorporate the technology.
The subject of the agreement is the definitive spelling out of rights for the commercialization of what the Company refers to as "generation one" spider silk technology. The agreement confirms the Company's exclusive right to the commercial development of spider silk textiles derived from the subject technology.
"Due to the significance of this technology it was important that we craft an agreement that benefits Kraig, our shareholders and the University," stated Kim Thompson, Company CEO and founder. "We are very happy to welcome the University of Notre Dame as our newest shareholder. We are also very happy to formally consummate this commercial license agreement covering the commercial rights to this exciting technology which we have been developing with the University."
"Our collaboration with university laboratories has been fundamental to the rapid progress we have made in the development of spider silk," Thompson continued. "The commercial license agreement reflects that sentiment and lays the groundwork for the Company's commercialization of spider silk technologies."
ILNS doesn't mind spending $$$ on PR's.
ILNS Oct. 26, 2011 Intellect Neurosciences, Inc.,
(OTCBB:ILNS.ob, a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment of Alzheimer's and other neurological diseases announces today the commencement of the initial development of its new CONJUMAB-A platform technology for a novel class of therapeutics for treatment of Alzheimer's disease and other proteinopathies based on antibody-drug conjugates (ADCs). Dr. Daniel G. Chain, the Company's Chairman and CEO and inventor of the CONJUMAB-A technology, will provide a brief description of the CONJUMAB-A technology during his presentation at BioInvestor Forum 2011 and in a video interview at the World ADC Summit, both taking place in San Francisco this week.
The new ADC- based technology has the potential to improve on current methods of passive immunotherapy by increasing clearance of amyloid proteins while delivering potent cytoprotective molecules to sites of damage in the brain and other organs. CONJUMAB-A is designed to reduce inflammation caused by amyloidosis while avoiding vasogenic edema, a side effect of plaque dissolution that occurs in some patients. The company's lead CONJUMAB-A candidate is IN-N01-OX2, a non-activating, stabilized IgG4 humanized antibody specific for beta amyloid protein conjugated to melatonin, which is a naturally occurring molecule with potent anti-oxidant and anti-fibrillogenic properties.
"We believe this exciting new approach may herald a new generation of promising drug candidates for the treatment of currently untreatable life-threatening diseases. CONJUMAB-A capitalizes on the tremendous advances already made in the area of ADCs for cancer which have generated a plethora of advanced enabling drug conjugation technologies and also uses independent approaches," said Daniel Chain, Ph.D., Chairman and CEO of Intellect Neurosciences and inventor of the CONJUMAB-A technology. "While CONJUMAB-A is still at the earliest stage of development and requires substantial work before new drug candidates can be tested in human clinical trials, we are very optimistic regarding its potential, and look forward to reporting our progress as soon as possible."
Intellect's new platform may also have applications for in vivo imaging of amyloid, which may be useful for diagnosis of disease and monitoring of drug effectiveness. The Company has applied for a patent for its CONJUMAB-A technology. Intellect has the exclusively license to certain patents granted by the USPTO to NYU School of Medicine and the University of South Alabama Research Foundation specifically covering the use of melatonin for the treatment of Alzheimer's disease and other types of amyloidosis. The CONJUMAB-A platform is applicable to a broad range of diseases including, Alzheimer's, Parkinson's, Huntington's, Age-Related Macular Degeneration, Glaucoma, Cerebral Angiopathy, Frontotemporal Dementia, Progressive Supranuclear Palsy, Pick's disease, Cortical Basal Degeneration and Peripheral Amyloidosis.
ILNS Form 8-K for INTELLECT NEUROSCIENCES, INC.
17-Oct-2011
Change in Directors or Principal Officers
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
Effective as of October 17, 2011, Mr. Elliot Maza is relinquishing his duties as President of Intellect Neurosciences, Inc. The change does not result from any disagreements between the Company and Mr. Maza.
ILNS Intellect Neurosciences Issues Letter to Shareholders
NEW YORK, Oct. 14, 2011 /PRNewswire/ -- Intellect Neurosciences, Inc. (OTCBB:ILNS.ob - News), a biopharmaceutical company engaged in the discovery and development of disease-modifying therapeutic agents for the treatment of Alzheimer's and other neurological diseases today issued the following Letter to Shareholders from Dr. Daniel Chain, Chairman and CEO.
Dear Shareholder,
I would like to take this opportunity to update you about pertinent corporate and industry developments contemporaneous with the current filing of our quarterly financial statements with the SEC.
Of special note is our recent transaction with ViroPharma Inc., which was announced September 30, 2011. Intellect granted an exclusive license to ViroPharma regarding certain of Intellect's licensed patents and patent applications related to Intellect's clinical stage drug candidate, OX1, an extremely potent antioxidant molecule that has been demonstrated to protect nerve cells in the brain from highly oxidizing neurotoxins. ViroPharma plans to develop and commercialize OX1 as a treatment of Friedreich's Ataxia and possibly other diseases for which OX1 may qualify for orphan drug designation. Under the terms of the license agreement, Intellect received an upfront payment of $6.5 million, and will receive up to an additional $120 million based on defined events and a tiered royalty of up to a maximum of low double digits based on annual net sales. In exchange, Intellect transferred to ViroPharma all of Intellect's intellectual property rights, data and know-how, assembled over several years related to its OX1 research and development program. NYU Medical School and University of South Alabama, which own certain patents in relation to OX1, are entitled to a portion of the revenues received by Intellect from ViroPharma pursuant to an exclusive license agreement between Intellect Neurosciences and those universities.
I am particularly gratified by the interest shown in the OX1 program by ViroPharma and several other large pharmaceutical companies. I have championed and led the development of this promising compound since its exciting therapeutic potential was first discovered by scientists at NYU Medical School and University South Alabama in the late 1990s. I am confident that OX1 will be in good hands with ViroPharma, whose ample resources, drug development capabilities and marketing expertise provide the ideal environment to accelerate the development and commercialization of the compound for the ultimate benefit of patients in desperate need of treatment. In fact, Jennifer Farmer, MS, CGC, Executive Director, of the Friedreich's Ataxia Research Alliance ("FARA") wrote to me on September 30th saying, "There is lots of excitement in the FA community with this announcement today."
Intellect has entered into several previous licensing transactions with top-tier global pharmaceutical companies, in which it granted non-exclusive licenses to its ANTISENILIN® technology and intellectual property relating to antibodies and methods of treating Alzheimer's disease. Thus, in addition to the future milestone and royalty payments we may receive from ViroPharma in relation to OX1, we may receive royalty payments from other companies pending successful commercialization of certain Alzheimer's drugs that rely on the ANTISENILIN® technology .
Internal Pipeline:
Following the successful licensing of the OX1 technology and ANTISENILIN® patents, we are now turning our attention to other technologies, with the aim of creating additional high-value assets that will attract future revenue-generating partnerships with large pharmaceutical companies. Intellect plans to continue to build its IP and technology portfolio and develop ground-breaking treatments for Alzheimer's disease and other neurodegenerative diseases - especially focused on proteinopathies, which include Huntington's disease, Parkinson's disease, Alzheimer's disease, age-related macular degeneration, glaucoma, traumatic brain injury, cerebral amyloid angiopathy and other disorders. Our pipeline includes OX2, a neuroprotective small molecule, and neoepitope-based immunotherapy approaches, including monoclonal antibodies and vaccines targeting beta amyloid and abnormal tau proteins.
Virtual R&D Operations:
As is increasingly the norm among emerging pharmaceutical and biotechnology companies, Intellect conducts its drug discovery and development operations using specialized independent subcontractors, expert consultants and academic collaborators. Virtual R&D allows us to take on multiple discovery/ development opportunities without investing in facilities and specific capabilities that can be handled efficiently by external consultants and contractors. Our in-house team and key consultants provide the essential oversight and direction, while use of external contractors allows us to take "more shots on goal" to increase the likelihood of producing viable products in a shorter period of time. Not only does this increase our chances of achieving commercialization of new drug treatments, it gives us flexibility, including the option of terminating programs that are not able to advance to the next level and quickly shifting resources to accelerating the programs that are demonstrating the most promising results.
The small management team at Intellect belies its extraordinary productivity. From a streamlined team, Intellect has achieved the development of several drugs now in advanced clinical trials by large pharmaceutical companies, as well as an extremely valuable IP portfolio that is the envy of many, much larger pharmaceutical companies. Moreover, we have established a truly pre-eminent network among foremost industry leaders. We are especially grateful for the assistance we received from Dr. Michael Grundman with the OX1 program, which we licensed to ViroPharma.
Dr. Grundman, who recently joined Intellect's Clinical Advisory Board, is president and CEO of Global R&D Partners, LLC, a consulting firm that works closely with pharmaceutical and biotechnology companies to develop novel agents for the diagnosis and treatment of serious and life-threatening diseases. Dr. Grundman previously served as vice president of clinical development at Janssen Alzheimer Immunotherapy Research & Development, LLC and as vice president of clinical development at Elan Pharmaceuticals. Dr Paul E. Bendheim, who chairs Intellect's Clinical Advisory Board, also played an important role in the development of OX1, and assisted us recently in finalizing the Phase 1b report.
Patents:
We continue to make progress in regards to obtaining a US patent for our ANTISENILIN® technology platform, which is the subject of our royalty-bearing license agreements with several major pharmaceutical companies. Under the terms of our license agreements, we are entitled to significant milestone payments upon issuance of a US patent on our application by the United States Patent and Trademark Office ("USPTO"). Corresponding patents have been issued in Europe, Japan, China and several other countries. We previously overcame six previous Office Actions causing the examiner in each case to withdraw his rejections of claims. Recently, an independent, world renown, Boston-based academician who is a recognized expert in therapeutic antibodies provided a written declaration in support of our latest response to an Official Action by the USPTO.
This latest development further bolsters our confidence that we will be granted a US patent, which will trigger the milestone payments and greatly increase the royalties payable to Intellect when drugs based on its technology reach the market. We expect a decision from the USPTO on our ANTISENILIN® patent applications within the next several months, including the application relating to methods of treatment and that relating to composition of matter.
We attended Oral Proceedings at the European patent office in The Hague, Netherlands in July and were disappointed by the decision taken by the Opposition Division to revoke the ANTISENILIN patents in response to opposition proceedings that were instituted against us by Elan Pharmaceuticals and Wyeth. The Oral Proceedings were attended by Counsel for Elan/Johnson & Jonhson, Wyeth and its parent Pfizer, each of which have drugs in advanced clinical trials that would be covered by the claims in our patent. The decision will be appealed and we remain confident regarding our ability to prevail at the level of the higher Appeals Board in Munich, Germany. Importantly, Intellect's patents remain in full force in key European countries pending the outcome of the appeal process, which is expected to take at least two years. Moreover, Intellect has filed divisional patent applications, which we believe will result in robust new patents in Europe that will be resistant to challenge and similarly cover the products currently in clinical development.
Financial Results for the Fiscal Year Ended June 30, 2011:
Our net income for the year ended June 30, 2011 was $2,425,113 compared to a net loss of $33,047,726 for the year ended June 30, 2010. This improvement of $35,472,839 primarily was due a decrease in interest expense of approximately $34,400,000 and a reduction in SG&A expenses of approximately $976,000. The decrease in SG&A expenses, which reduced our cash outflows, resulted from our efforts to contain costs. The reduction in interest expense did not affect our cash position because this interest expense is a non-cash charge related to the value of certain securities issued to shareholders and note holders.
Our Research and Development Costs for the year ended June 30, 2011 were $105,793 compared to $58,974 for the year ended June 30, 2010. The increase of $46,819 was due to increased R&D activities with respect to our clinical drug candidate OX1, which we subsequently licensed to ViroPharma.
Currently, there are 72,751,143 shares of common stock issued and outstanding.
Developments in Alzheimer's Research:
I had the pleasure of attending the annual Alzheimer's Association International Conference (ICAD) in Paris, France, in July. The conference drew a record-breaking number of dementia scientists to share the latest ideas, thoughts and theories in the field. Breaking studies captured global media attention as the world's leading experts explored innovative ways to further Alzheimer's research. The conference was also attended by senior executives from several major pharmaceutical companies with whom we had the opportunity to discuss Intellect's technology and pipeline.
While the whole scientific world is waiting to see the outcome of Bapineuzumab phase 3 clinical trials which are expected to conclude next year, a strong second front is starting to form in the battle against Alzheimer's disease supporting our long-held conviction that beta amyloid has a crucial partner in tau protein (See our video on http://www.youtube.com/watch?v=STmiIVCFskA). Indeed beta amyloid accumulating on the surface of nerve cells and tangles comprised of tau inside the cells are two hallmark features of the disease. Although both beta amyloid and tau have been extensively studied individually with regard to their separate modes of toxicity, more recently new light has been shed on their possible interactions and synergistic effects in Alzheimer's disease. It is important to note, however, that the recent developments regarding tau protein research which has been widely reported in the media, including in the New York Times in August, do not at all diminish the importance of beta amyloid or teach away from the amyloid cascade hypothesis which postulates that formation of beta amyloid is the critical step in driving Alzheimer's disease pathogenesis. Indeed this concept has strong support such as from the identification of pathogenic mutations in patients with Familial Alzheimer's disease that are linked to beta amyloid formation, as well as increased beta amyloid levels and a higher frequency of Alzheimer's disease in people with Down's syndrome, who over produce beta amyloid due to a genetic defect. Therefore, a crucial question is where tau is to be placed in the amyloid cascade. Is it a prime target, a mediator or a kind of bystander of beta amyloid toxicity? Although beta amyloid and tau exert toxicity through separate mechanisms, evidence from both in vitro and in vivo models suggests that beta amyloid and tau act in tandem to cause irreversible damage to nerve cells including loss of connections. Intellect Neurosciences has previously evolved its technology to address this possibility and boasts a dual target vaccine among its arsenal of drugs being developed to combat Alzheimer's disease and certain other related disorders.
Increased public awareness:
We have continued our efforts to increase public and investor awareness of Intellect Neurosciences through media outreach and other activities including speaking at conferences.
Notably, I accepted an invitation to speak at the Phacilitate CNS Leaders Forum November 7-9 in Boston in which senior corporate and development executives from major pharmaceutical companies comprise the majority of speakers. My talk is the first in a focus session which is entitled "Plotting a path forward to effective Phase II clinical trial design for neurodegenerative diseases". Following speakers during the session include Dr Susan Abu Shakra, Vice President & Program Lead, Alzheimer's Disease, Elan Corporation, Dr Charles Albright, Executive Director, Neuroscience, Bristol-Myers Squibb and Professor David Leppert, Clinical Science Leader, F. Hoffmann-La Roche Ltd. Details of the conference can be found at www.phacilitate.co.uk/pages/leaders/cns_agenda_d1_s2.html. In addition, we were approved by the 2011 Selection Committee of the Biotechnology Industry Organization (BIO), to give a 25-minute corporate presentation taking place October 25th – 26th, 2011 in San Francisco.
The announcement of the transaction with ViroPharma was widely disseminated and the news has been reported in professional magazines such as BioCentury which is widely read by industry professionals and investors.
We recently engaged JQA Partners, LLC Strategic Communications, a public relations firm with more than 15 years' service, mainly focused on healthcare, including Big Pharma and biotech. The key objectives are: (1) Position Intellect Neurosciences as a premiere drug discovery company with significant IP and deep capabilities in Alzheimer's disease and beyond; (2) Drive partnerships based on emerging pre-clinical and IP portfolio; (3) Attract investor interest in the company
Conclusion:
Our announcement of a lucrative licensing agreement on September 30, 2011 demonstrates that we were fully justified regarding our expectations to partner OX1 pending completion of Phase 1 clinical trials and that we successfully executed on these plans (see shareholder letter of September 8, 2010). Similarly, we believe our current plans to build on our existing IP and technologies through cost-effective R&D and IP strategies will pay dividends in the future and allow us to continue with our mission to develop treatments for patients suffering from devastating neurodegenerative conditions.
We thank you for your continued support of our important mission and vision to create a world without Alzheimer's disease and other serious neurological disorders.
Sincerely,
Daniel Chain, PhD, Chairman and Chief Executive Officer
Safe Harbor Statement Regarding Forward-Looking Statements:
The statements in this release and oral statements made by representatives of Intellect relating to matters that are not historical facts (including, without limitation, those regarding future performance or financial results, the timing or potential outcomes of research collaborations or clinical trials, any market that might develop for any of Intellect's product candidates and the sufficiency of Intellect's cash and other capital resources) are forward-looking statements that involve risks and uncertainties, including, but not limited to, the likelihood that actual performance or results could materially differ, that future research will prove successful, the likelihood that any product in the research pipeline will receive regulatory approval in the United States or abroad, or Intellect's ability to fund such efforts with or without partners. Intellect undertakes no obligation to update any of these statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as to the date hereof. Accordingly, any forward-looking statements should be read in conjunction with the additional risks and uncertainties detailed in Intellect's filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in Intellect's Annual Report on Form 10-K (file no. 333-128226), filed on October 13, 2011.
Contact:
Jules Abraham, PR Manager for Intellect Neurosciences
Principal
JQA Partners, LLC
917-885-7378
jabraham@jqapartners.com
http://finance.yahoo.com/news/Intellect-Neurosciences-prnews-3414323722.html?x=0&.v=1
ILNS Form 10-K INTELLECT NEUROSCIENCES, INC.
13-Oct-2011
Annual Report
ITEM 7. MANAGEMENTS'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis should be read in conjunction with the Consolidated Financial Statements included elsewhere in this report and the information described under the caption "Risk Factors" and "Special Note Regarding Forward Looking Statements" above.
General
We are a biopharmaceutical company developing and advancing a patent portfolio related to specific therapeutic approaches for treating Alzheimer's disease ("AD"). In addition, we are developing proprietary drug candidates to treat AD and other diseases associated with oxidative stress.
Since our inception in 2005, we have devoted substantially all of our efforts and resources to advancing our intellectual property portfolio and research and development activities. We have entered into license and other agreements with large pharmaceutical companies related to our patent estate, however, neither we nor any of our licensees have obtained regulatory approval for sales of any product candidates covered by our patents. We operate under a single segment. Our fiscal year end is June 30.
Our core business strategy is the licensing of our intellectual property and development of innovative therapeutics that we have purchased, developed internally or in-licensed from universities and others. We seek to complete human proof of concept (Phase II) studies and then enter into collaboration agreements, licenses or sales to complete product development and commercialize the resulting drug products. We intend to obtain revenues from licensing fees, milestone payments, development fees, royalties and/or sales related to the use of our drug candidates or intellectual property for specific therapeutic indications or applications.
Our most advanced drug candidate, OX1 (OX1), is a chemically synthesized form of a small, potent, dual mode of action, naturally occurring molecule. We commenced human Phase I clinical trials for OX1 on December 1, 2005 in the Netherlands and completed Phase I clinical trials on November 15, 2006. In September 2011, we granted an exclusive license to ViroPharma regarding certain of our licensed patents and patent applications related to OX1 in exchange for payment by ViroPharma of a $6.5 million up-front licensing fee and additional regulatory milestone payments based upon defined events in the United States and the European Union. ViroPharma expects to develop and commercialize OX1 as a treatment of Friedreich's Ataxia and possibly other diseases for which OX1 may qualify for orphan drug designation.
Our pipeline includes drugs based on our immunotherapy platform technologies, ANTISENILIN and RECALL-VAX. These immunotherapy programs are based on monoclonal antibodies and therapeutic vaccines, respectively, to prevent the accumulation and toxicity of the amyloid beta toxin. Both are in pre-clinical development. Our lead product candidate in our immunotherapy programs is IN-N01, a monoclonal antibody that has undergone certain procedures in the humanization process at MRCT in the UK.
Our current business is focused on granting licenses to our patent estate to large pharmaceutical companies and on research and development of proprietary therapies for the treatment of AD through outsourcing and other arrangements with third parties. We expect research and development, including patent related costs, to continue to be the most significant expense of our business for the foreseeable future. Our research and development activity is subject to change as we develop a better understanding of our projects and their prospects. Total research and development costs from inception through June 30, 2011 were $13,436,564.
Results of Operations
Year Ended June 30, 2011 Compared to the Year Ended June 30, 2010:
Year Ended June 30,
(in thousands)
2011 2010 Change
Loss from operations (3,532 ) (4,293 ) 761
Other income (expenses): 5,957 (28,754 ) 34,711
Net income / (loss) $ 2,425 $ (33,047 ) $ 35,472
Year Ended June 30,
(in thousands)
2011 2010 Change
Research and Development Costs 106 59 47
General and Administrative 3,426 4,234 (808 )
Loss from operations $ 3,532 $ 4,293 $ (761 )
Our net income for the year ended June 30, 2011 was $2,425,113 compared to a net loss of $33,047,726 for the year ended June 30, 2010. This improvement of $35,472,839 primarily was due a decrease in interest expense of $34,415,680, a reduction in, general and administrative and research and development expenses of $761,407. In addition our net income is also affected by the change in fair value of our derivative liabilities resulting from the recording of the fair value of warrants issued in our financing, a beneficial conversion feature embedded in our convertible promissory notes that were issued, and the preferred stock liability which is stated at fair value relating to our Series B Preferred Stock. We recognized a gain of $12,161,870 for the year ending June 30, 2011 as compared to a gain of $11,944,010 for the year ending June 30, 2010.
For year end June 30, 2010 we recorded an immediate interest charge of $37,883,883 relating to the fair value of the warrant liability and beneficial conversion feature associated with the issuance of convertible debt, as compared to approximately $6,137,741 for the year ended June 30 2011. The additional reduction in interest expense related to a lower average indebtedness outstanding during the year ended June 30, 2011 as compared to the year ended June 30, 2010.
Our General and Administrative Expenses for the year ended June 30, 2011 were $3,426,094 compared to $4,234,320 for the year ended June 30, 2010. The decrease of $803,226 primarily was due to a decrease in consulting and investor relations fees. Our Research and Development Costs for the year ended June 30, 2011 were $105,793 compared to $58,794 for the year ended June 30, 2010. The increase of $46,999 was due to increased R&D activities with respect to our clinical drug candidate OX1.
We have recorded a 100% valuation allowance against the deferred tax asset consisting of available net operating loss carry forwards and derivative liabilities and accordingly no income tax benefit was provided.
Impact of Inflation
The impact of inflation upon our revenue and income/(loss) from continuing operations during each of the past two fiscal years has not been material to our financial position or results of operations for those years because we have no products for sale and do not maintain any inventories whose costs are affected by inflation.
Liquidity and Capital Resources
Since our inception in 2005, we have mainly generated losses from operations and we anticipate that we will continue to generate significant losses from operations for the foreseeable future. As of June 30, 2011 and 2010, our deficit accumulated during the development stage was $87,848,906 and $75,224,019, respectively. Our loss from operations for the years ended June 30, 2011 and 2010 was $3,531,887 and $4,293,294, respectively. Our cash used in operations was $2,161,931 and $2,223,071for the years ended June 30, 2011 and 2010, respectively. Our capital deficiency was $26,413,919 and $20,312,121 as of June 30, 2011 and 2010, respectively.
We have limited capital resources and operations since inception have been funded with the proceeds from equity and debt financings and license fee arrangements. As of June 30, 2011, we had cash and cash equivalents of $101,325. In September 2011, we granted an exclusive license to ViroPharma regarding certain of our licensed patents and patent applications related to OX1 in exchange for payment by ViroPharma of a $6.5 million up-front licensing fee and additional regulatory milestone payments based upon defined events in the United States and the European Union. We anticipate that our existing capital resources will enable us to continue operations for the next eighteen to twenty four months. However, our business will require substantial additional investment that we have not yet secured. We cannot be sure how much we will need to spend in order to develop new products and technologies in the future. Further, we will not have sufficient resources to develop fully any new products or technologies unless we are able to raise substantial additional financing on acceptable terms or secure funds from new or existing partners. If we fail to raise additional capital or obtain substantial cash inflows from existing or potential partners within the next twenty four months, we will be unable to successfully develop and commercialize our products. We cannot assure you that financing will be available in a timely manner, on favorable terms or at all.
The audit report prepared by our independent registered public accounting firm relating to our consolidated financial statements for the year ended June 30, 2011 includes an explanatory paragraph expressing substantial doubt about our ability to continue as a going concern.
June 30, 2011 Financing
On June 30, 2011, we sold investment units for an aggregate purchase price of $100,000. Each unit consisted of a Convertible Promissory Note (the "June 2011 Notes") and warrants (the "June 2011 Warrants"). Total proceeds from the sale of these investment units were $100,000.
The June 2011 Notes have an aggregate face amount of $100,000, are due on June 30, 2014 and bear interest at 14%, payable at maturity. The June 2011 Notes are convertible into 2 million shares of our Common stock. The June 2011 Warrants entitle the holders to purchase up to 10 million shares of our Common Stock.
During July 2011, we sold an additional $150,000 of investment units with the same terms as the June 2011 Notes and Warrants.
March 14, 2011 Financing Transaction
On March 14, 2011, we sold investment units for an aggregate purchase price of $500,000. Each unit consisted of a Convertible Promissory Note (the "March 2011 Notes"), shares of Series C Convertible Preferred Stock ("Series C Prefs") and warrants (the "March 2011 Warrants"). Total proceeds from the sale of these investment units were $500,000.
The March 2011 Notes have an aggregate face amount of $500,000, are due on March 14, 2014 and bear interest at 14%, payable at maturity. As a result of the ratchet provisions contained in the March 2011 Notes, the holders are entitled to convert the Notes into 10 million shares of our Common Stock. We issued to the purchasers of the March 2011 Notes an aggregate of 10,000 shares of Series C Prefs with an initial aggregate liquidation preference equal to $10 million. As a result of the ratchet provisions contained the Certificate of Designation of the Series C Preferred Stock, the Series C Prefs are convertible into 200 million shares of our common stock. As a result of the ratchet provisions contained in the terms of the March 2011 Warrants, the holders are entitled to purchase up to 10 million shares of our Common Stock.
December 15, 2010 Financing Transactions
On December 15, 2010, we sold investment units for an aggregate purchase price of $500,000. Each unit consisted of a Convertible Promissory Note (the "December 2010 Notes"), Series C Prefs and warrants (the "December 2010 Warrants"). Total proceeds from the sale of these investment units were $500,000.
The December 2010 Notes have an aggregate face amount of $500,000, are due on December 15, 2013 and bear interest at 14%, payable at maturity. As a result of the ratchet provisions contained in the December 2010 Notes, the holders are entitled to convert the Notes into 10 million shares of our Common Stock. We issued to the purchasers of the December 2010 Notes an aggregate of 10,000 shares of Series C Prefs with an initial aggregate liquidation preference equal to $10 million. As a result of the ratchet provisions contained the Certificate of Designation of the Series C Preferred Stock, the Series C Prefs are convertible into 200 million shares of our common stock. As a result of the ratchet provisions contained in the terms of the December 2010 Warrants, the holders are entitled to purchase up to 10 million shares of our Common Stock.
As a result of the "ratchet" provisions contained in the April 2010 Notes described below and outstanding Warrants, the conversion price of the remaining outstanding April 2010 Notes and exercise price of our outstanding Warrants were adjusted to $0.05 per common share. The conversion price of previously issued and outstanding Series B Convertible Preferred Stock held by holders other than the purchasers of the April 2010 Notes is not subject to adjustment as a result of the issuance of the December 2010 Notes.
In January 2011, as a result of the "ratchet" provisions contained in the April 2010 Notes, we issued to purchasers of the April 2010 Notes remaining outstanding an additional 2,000 shares of our Series C Convertible Preferred Stock with an initial aggregate liquidation preference equal to $2 million, which are convertible into 40 million shares of our common stock.
Issuance of Securities on April 23, 2010.We sold investment units for an aggregate purchase price of $2,320,000. Each unit consisted of a Secured Convertible Promissory Note (the "2010 Notes"), shares of our common stock, and Class A, Class B and Class C warrants. We issued a total of 1,160,000 shares of our common stock and 1,546,667 of each Class A Warrants, Class B Warrants and Class C Warrants. The 2010 Notes have an aggregate principal amount of $580,000, are due April 22, 2013, bear interest at 14%, payable at maturity, and are secured by all of our assets, including the net proceeds from the transaction that have been retained in the escrow account. At the option of the holder, principal and all accrued interest is convertible into our common stock at a price of $1.50 per common share. Net proceeds from the sale of the securities were approximately $2,025,000, after taking into account repayment of the November Notes. The net proceeds were placed in escrow and were distributed to us on a monthly basis pursuant to the terms of an Escrow Agreement.
Repayment of Outstanding Promissory Notes. Effective April 23, 2010, all the holders of the 2007 Notes accepted shares of our common stock in repayment of their 2007 Notes and agreed to the cancellation of their warrants (except for holders owning notes with an aggregate principal amount of $310,000 and 3,543 warrants). All such notes were past due and in default. Each holder received a number of shares of our common stock equal to the sum of the full principal amount of his or her notes, plus all accrued and unpaid interest, divided by
2.50. Holders of notes who purchased investment units in the April 2010 Financing for total consideration of at least $500,000 received a number of shares of our common stock equal to the sum of the full principal amount of the notes held by such purchasers prior to the April 2010 Financing, plus all accrued and unpaid interest on such notes, divided by 1.50. In connection with the repayment of the outstanding promissory notes, each holder agreed to the cancellation of his or her existing warrants that were issued in connection with the original issuance of the Notes. In addition, each holder agreed not to sell, transfer or pledge any shares of our common stock received upon repayment of his or her notes for a period of one year. In addition, all of the holders of the 2008 Notes accepted shares of our common stock in repayment of their 2008 Notes and agreed to the cancellation of their warrants and all of the holders of the Royalty Notes accepted shares of our common stock in repayment of their Royalty Notes and agreed to the cancellation of their warrants.
The holders of the November Notes exchanged an amount equal to the principal component of the November Notes for investment units and accepted shares of our common stock in payment of the accrued interest and the escrow agent released the Purchaser Shares to them. We subsequently issued 1,000 replacement shares to our CEO.
Conversion of Outstanding Series B Convertible Preferred Stock. Effective April 23, 2010, all of the holders of the Series B Preferred (except holders owning Series B Preferred with an aggregate liquidation preference of $1,870,380 and 8,497 warrants) exercised the conversion feature contained in the Series B Preferred and exchanged their securities for shares of our common stock and agreed to the cancellation of their Series B Warrants.
We issued 26,543 shares of our common stock and 14,000 warrants to purchase shares of our common stock to various consultants in connection with transactions referred to above.
Off -Balance Sheet Arrangements
As of June 30, 2011, we had no material off-balance sheet arrangements other than obligations under various agreements as follows:
Under a License Agreement with NYU and a similar License Agreement with University of South Alabama Medical Science Foundation ("SAMSF") related to our OX1 program, we are obligated to make future payments totaling approximately $1.5 million to each of NYU and SAMSF upon achievement of certain milestones based on phases of clinical development and approval of the FDA (or foreign equivalent) and also to pay each of NYU and SAMSF a royalty based on product sales by Intellect or royalty payments received by Intellect. In September 2011, we granted a sublicense of the License Agreements to ViroPharma pursuant to which we received a $6.5 million up-front licensing fee and are entitled to receive additional regulatory milestone payments based upon defined events in the United States and the European Union. Pursuant to the terms of the License Agreements, we are obligated to pay each of SAMS and NYU $650,000 of the up-front licensing fee and a portion of future payments we may receive from ViroPharma.
Mindset acquired from Mayo Foundation for Medical Education and Research ("Mayo") a non-exclusive license to use certain transgenic mice as models for AD and is obligated to pay Mayo a royalty of 2.5% of any net revenue that Mindset receives from the sale or licensing of a drug product for AD in which the Mayo transgenic mice were used for research purposes. The Mayo transgenic mice were used by the SAMSF to conduct research with respect to OX1. Pursuant to the Assignment that we executed with the SAMSF, we agreed to assume Mindset's obligations to pay royalties to Mayo. We have not received any net revenue that would trigger a payment obligation to Mayo.
Pursuant to a Letter Agreement with the Institute for the Study of Aging, we are obligated to pay a total of $225,500 of milestone payments contingent upon future clinical development of OX1.
Under a Research Agreement with MRC Technology ("MRCT"), we are obligated to make future research milestone payments totaling approximately $560,000 to MRCT related to the development of the 82E1 humanized antibody and to pay additional milestones related to the commercialization, and a royalty based on sales, of the resulting drug products. MRCT has achieved certain of the research milestones and we have included $350,000 of the total $560,000 in accrued expenses.
Under the terms of a Beta-Amyloid Specific, Humanized Monoclonal Antibody Purchase and Sale Agreement with Immuno-Biological Laboratories Co., Ltd ("IBL"), we agreed to pay IBL a total of $2,125,000 upon the achievement of certain milestones plus a specified royalty based on sales of any pharmaceutical product derived from the 82E1or 1A10 antibodies. We have paid $40,000 to date.
Under the terms of a Royalty Participation Agreement effective as of July 31, 2008, certain of our lenders are entitled to an aggregate share of 25% of future royalties that we receive from the license of our ANTISENILIN patent estate.
In the ordinary course of business, we enter into agreements with third parties that include indemnification provisions which, in our judgment, are normal and customary for companies in our industry sector. These agreements are typically with business partners, clinical sites, and suppliers. Pursuant to these agreements, we generally agree to indemnify, hold harmless, and reimburse indemnified parties for losses suffered or incurred by the indemnified parties with respect to our product candidates, use of such product candidates, or other actions taken or omitted by us. The maximum potential amount of future payments we could be required to make under these indemnification provisions is unlimited. We have not incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. As a result, the estimated fair value of liabilities relating to these provisions is minimal. Accordingly, we have no liabilities recorded for these provisions as of June 30, 2011 or 2010.
In the normal course of business, we may be confronted with issues or events that may result in a contingent liability. These generally relate to lawsuits, claims, environmental actions or the actions of various regulatory agencies. We consult with counsel and other appropriate experts to assess the claim. If, in our opinion, we have incurred a probable loss as set forth by accounting principles generally accepted in the United States, an estimate is made of the loss and the appropriate accounting entries are reflected in our consolidated financial statements. After consultation with legal counsel, we do not anticipate that liabilities arising out of currently pending or threatened lawsuits and claims will have a material adverse effect on our consolidated financial position, results of operations or cash flows.
Critical Accounting Estimates and New Accounting Pronouncements
Critical Accounting Estimates
The preparation of financial statements in accordance with accounting principals generally accepted in the United States requires management to make estimates and assumptions that affect reported amounts and related disclosures in the financial statements. Management considers an accounting estimate to be critical if it requires assumptions to be made that were uncertain at the time the estimate was made, and changes in the estimate or different estimates that could have been selected could have a material impact on our consolidated results of operations or financial condition.
Convertible Instruments We evaluate and account for conversion options embedded in convertible instruments in accordance with ASC 815 "Derivatives and Hedging Activities".Applicable GAAP requires companies to bifurcate conversion options from their host instruments and account for them as free standing derivative financial instruments according to certain criteria. The criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under other GAAP with changes in fair value reported in earnings as they occur and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument.
We account for convertible instruments (when we have determined that the embedded conversion options should not be bifurcated from their host instruments) as follows: We record when necessary, discounts to convertible notes for the intrinsic value of conversion options embedded in debt instruments based upon the differences between the fair value of the underlying common stock at the commitment date of the note transaction and the effective conversion price embedded in the note. Debt discounts under these arrangements are amortized over the term of the related debt to their stated date of redemption. We also record when necessary, deemed dividends for the intrinsic value of conversion options embedded in preferred shares based upon the differences between the fair value of the underlying common stock at the commitment date of the transaction and the effective conversion price embedded in the preferred shares.
Common Stock Purchase Warrants We classify as equity any contracts that require physical settlement or net-share settlement or provide us a choice of net-cash settlement or settlement in our own shares (physical settlement or net-share settlement) provided that such contracts are indexed to our own stock as defined in ASC 815-40 ("Contracts in Entity's Own Equity"). We classify as assets or liabilities any contracts that require net-cash settlement (including a requirement to net cash settle the contract if an event occurs and if that event is outside our control) or give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). We assess classification of our common stock purchase warrants and other free standing derivatives at each reporting date to determine whether a change in classification between assets and liabilities is required.
Preferred Stock. We apply the guidance enumerated in ASC 480 "Distinguishing Liabilities from Equity" when determining the classification and measurement of preferred stock. Preferred shares subject to mandatory redemption (if any) are classified as liability instruments and are measured at fair value. We classify conditionally redeemable preferred shares (if any), which includes preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within our control, as temporary equity. At all other times, we classified our preferred shares in stockholders' equity.
Derivative Instruments. Our derivative financial instruments consist of embedded derivatives related to the convertible debt, warrants and beneficial conversion features embedded within our convertible debt. The accounting treatment of derivative financial instruments requires that we record the derivatives and related warrants at their fair values as of the inception date of the debt agreements and at fair value as of each subsequent balance sheet date. Any change in fair value was recorded as non-operating, non-cash income or expense at each balance sheet date. If the fair value of the derivatives was higher at the subsequent balance sheet date, we recorded a non-operating, non-cash charge. If the fair value of the derivatives was lower at the subsequent balance sheet date, we recorded non-operating, non-cash income.
Research and Development Costs and Clinical Trial Expenses. Research and development costs include costs directly attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes, employee benefits, materials, supplies, maintenance of research equipment, costs related to research collaboration and licensing agreements, the cost of services provided by outside contractors, including services related to our clinical trials, clinical trial expenses, the full cost of manufacturing drugs for use in research, preclinical development, and clinical trials. All costs associated with research and development are expensed as incurred.
Revenue Recognition. We recognize revenue in accordance with authoritative accounting guidance, which provides that non-refundable upfront and research and development milestone payments and payments for services are recognized as . . .
http://biz.yahoo.com/e/111013/ilns.pk10-k.html
ILNS Intellect Neurosciences and ViroPharma Announce $126.5 Million Global Licensing Agreement to Develop and Commercialize OX1 for Friedreich's Ataxia and Other Neurodegenerative Diseases
Intellect to Receive Upfront Payment of $6.5 Million, Potential Milestone Payments of $120 Million, and Royalty on Future Sales
Sept. 30, 2011 (GLOBE NEWSWIRE) -- Intellect Neurosciences, Inc. (OTCBB:ILNS.PK - News) announced today that Intellect has granted an exclusive License to ViroPharma Incorporated (Nasdaq:VPHM - News) regarding certain of Intellect's licensed patents and patent applications related to Intellect's clinical stage drug candidate, OX1, a multimodal, metal-binding, extremely potent antioxidant molecule, which has been demonstrated to protect nerve cells from highly oxidizing neurotoxins. ViroPharma plans to develop and commercialize OX1 as a treatment of Friedreich's Ataxia and possibly other diseases for which OX1 may qualify for orphan drug designation.
Under the terms of the Exclusive License Agreement, Intellect has agreed to transfer to ViroPharma all of Intellect's intellectual property rights, data and know-how related to its OX1 research and development program. In return, ViroPharma has agreed to pay a $6.5 million up-front licensing fee and will pay additional milestones based upon defined events. The maximum of these milestone payments assuming successful advancement to market could amount to $120 million. In addition, ViroPharma will pay a tiered royalty of up to a maximum of low double digits based on annual net sales.
Intellect recently announced completion of Phase 1 clinical trials for OX1. Dr. Daniel Chain, Intellect's Chairman and CEO, has played a leadership role in the development of OX1 since its therapeutic potential was originally discovered by scientists at NYU Medical School and University of South Alabama in the late 1990s. The universities, which own certain patents in relation to OX1, are entitled to a portion of revenues received by Intellect from any sale or license of OX1 pursuant to an exclusive license agreement between Intellect Neurosciences and the universities.
Dr. Chain commented: "We are pleased to enter into a strategic relationship with ViroPharma, which has ample resources, drug development capabilities and orphan drug marketing expertise to accelerate the development and commercialization of OX1. This transaction is the first for Intellect related to an internally developed compound. It is consistent with our business strategy to create high value assets that can generate revenues to support further development of drugs for the ultimate benefit of patients in desperate need of novel treatments for life-threatening conditions."
MSLP MusclePharm Strengthens Management Team Adding John H. Bluher as COO and EVP
DENVER, Sept. 20, 2011 /PRNewswire/ -- MusclePharm Corporation (OTCBB:MSLP.ob - News), an expanding U.S. nutritional supplement company ("MusclePharm" or the "Company"), is pleased to announce John H. Bluher has been named Chief Operating Officer and Executive Vice President for MusclePharm Corporation ("MSLP"). In announcing the new appointment, MusclePharm CEO Brad Pyatt said, "As COO, John brings us exceptional depth and balance. His broad range of experience with public companies, boards and financial structuring in addition to mergers and acquisitions will prove helpful as we are positioning MusclePharm for continued growth and profitability in 2012. He has proven abilities to realize the potential of an organization while rationalizing operational cost. We are extremely excited about how John will contribute to the further strengthening of MusclePharm's leadership position and growth prospects."
Mr. Bluher will immediately join the Executive Committee and the MSLP Board of Directors in October 2011. As COO, he reports to Mr. Pyatt and has responsibility for functional management and day-to-day operations. His long-range goals are to help with budgeting, managing MSLPs capital structure, structure departments as the company grows, develop control processes, and assist in developing supply chain management and inventory controls. Working closely with Mr. Bluher, Mr. Pyatt will now have time to focus on longer-range strategies, business development, extending the branding and marketing opportunities for MusclePharm. Finance, Legal, Operations, Investor Relations, Public Relations, and Administration report to Mr. Bluher. Mr. Bluher has been working as a consultant to MSLP for the past three months.
Mr. Bluher said: "I am excited for the opportunity to come into MusclePharm at such an important time for this young company. The company is growing at a tremendous pace and with the brand recognition accelerating, Brad felt that he needed someone focused full time on the internal controls, budgets, and financial and capital requirements of the company. Brad has aggressively built the brand and grown the company with innovative products, I will be focusing on building on his success so we can provide a return to our equity investors."
Mr. Bluher has significant experience working with corporate structuring, corporate boards and committees, risk management, and public company corporate governance. He has 20 years of experience working in financial services public companies as Chief Legal Officer, General Counsel, Director of Risk, and Chief Compliance Officer. Most recently he was Chief Legal Officer at Neuberger Berman and managed the sale of this company out of the Lehman Brothers estate. He was also General Counsel of the Investment Management Division of Lehman Brothers, Inc. His experience also includes negotiating transactions and purchases, and sales of assets and properties on a global basis. He has deep experience in creating and implementing corporate governance plans, working in the corporate board room, and as director of risk, developing internal audit programs and insurance programs for public companies.
He has served on the boards of ICI Mutual Insurance Company, the NASDAQ Chairman's Advisory Board, Cherry Hills Founders Group, Inc., and the University of Wyoming, College of Law Advisory Board. Mr. Bluher is currently on the Board of Targeted Medical Pharma, Inc., Safe Communications, Inc. and University of Wyoming Foundation Board.
MSLP MusclePharm Signs Two-Year Partnership With Ultimate Fighting Championship (UFC) as Official Nutritional Supplement Provider
DENVER, Sept. 19, 2011 /PRNewswire/ -- MusclePharm Corporation (OTCBB:MSLP.ob - News), an expanding U.S. nutritional supplement company ("MusclePharm" or the "Company"), is pleased to announce a two-year partnership agreement with the Ultimate Fighting Championship (UFC), as the Official Nutritional Supplement Provider for the premier Mixed Martial Arts organization in the world.
Regarded as one of the top sports nutrition companies in the industry, MusclePharm's association with the industry-leading UFC, which features the top MMA fighters in the world, is a perfect fit.
The UFC has experienced a massive rise in popularity over the last several years, giving MusclePharm the ideal platform to showcase its award-winning physique and performance product line.
The UFC is currently the largest pay-per-view content provider in the United States and its broadcasts have reigned supreme in the coveted 18-to-34 male ratings demographics. Drawing sell-out crowds across the world for its live events, the UFC has regularly earned higher television ratings than the NBA, NHL, NASCAR as well as NCAA football and basketball as it continues to move into the mainstream.
"We're excited to have MusclePharm as the official nutritional supplement provider of the UFC," UFC President Dana White said. "The team at MusclePharm is committed to helping grow the sport of mixed martial arts. Having them on board as a sponsor of UFC is great for our fans and athletes."
With the partnership, MusclePharm will now have exclusive in-ring placement, including its trademark MP logo on the Octagon mat and bumpers up to 10 times per year during UFC live events, which are viewed by millions of fans worldwide.
The map placement will be in place for the UFC's ground-breaking network television debut on FOX that takes place on Nov. 11. MusclePharm's strong presence will be evident on that night, as the UFC makes its network debut with a heavyweight championship fight between Cain Velasquez and Junior Dos Santos that will be seen by tens of millions of fans across the United States and will be one of the most-viewed matchups in UFC history.
In addition, the partnership includes strong digital media activation and will include an exclusive MusclePharm nutritional section on the www.UFC.com homepage, which draws millions of visitors each month.
The activation will also allow MusclePharm access and visibility on the UFC's Facebook and Twitter pages, which are considered some of the most popular in the social media world and include more than seven million fans.
MusclePharm has previously and continues to be a top sponsor for many of the UFC's top fighters, including worldwide superstars Anderson Silva, Quinton "Rampage" Jackson, Clay Guida and Rashad Evans.
Now, the growing company, which continues to draw rave reviews in the sports nutrition industry, will have a strong presence on www.ufc.com and inside the Octagon as this amazing partnership takes off.
ILNS doesn't have to back up the Note
with their intellectual property. That's my guess.
In other words, you take out a personal loan and the bank wants your house as collateral. Later, the bank decides they trust you so much that you don't have to risk losing your house.
What does that mean in layman terms?
Appears as somewhat good news for ILNS.
Don't follow company so only making assumptions from the recent 8-K.
Appears agreement between ILNS and holders of a convertible note has been terminated in that "the Holders agreed to release the security interests in various assets of the Company, including, without limitation, the Company's intellectual property,..."
Holder still holds convertible notes.
http://www.businessfinance.com/convertible-note.htm
What does this mean?
ILNS Form 8-K for INTELLECT NEUROSCIENCES, INC.
13-Sep-2011
Termination of a Material Definitive Agreement
Item 1.02. Termination of a Material Definitive Agreement.
On September 7, 2011, that certain Security Agreement (the "Security Agreement"), dated as of April 23, 2010, by and among Intellect Neurosciences, Inc. (the "Company"), the Company's subsidiaries, and the holders (the "Holders") of the Company's outstanding Convertible Notes dated April 23, 2010 (together, the "Parties"), and previously disclosed in and filed with the Securities and Exchange Commission (the "Commission") on April 29, 2010 as part of the Company's Current Report on Form 8-K dated April 23, 2010, was terminated pursuant to a Release and Termination Agreement, dated as of September 7, 2011 and by and among the Parties (the "Release and Termination Agreement").
Pursuant to the Release and Termination Agreement, the Holders agreed to release the security interests in various assets of the Company, including, without limitation, the Company's intellectual property, that were granted to the Holders pursuant to the Security Agreement and related agreements contemplated thereby, and the Parties agreed to terminate the Security Agreement effective immediately.
The Holders continue to hold the Company's Convertible Notes dated April 23, 2010, the form of which was filed with the Commission on April 29, 2010 as part of the Company's Current Report on Form 8-K dated April 23, 2010.
MSLP Form 10-Q for MUSCLEPHARM CORP
16-Aug-2011
Quarterly Report
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
This report and other reports filed by our Company from time to time with the SEC contain or may contain forward-looking statements and information that are based upon beliefs of, and information currently available to, our management as well as estimates and assumptions made by our management. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. When used in the filings, the words "anticipate," "believe," "estimate," "expect," "future," "intend," "plan," or the negative of these terms and similar expressions as they relate to us or our management identify forward-looking statements. Such statements reflect our current view with respect to future events and are subject to risks, uncertainties, assumptions, and other factors. Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to actual results.
Our financial statements are prepared in accordance with accounting principles generally accepted in the United States ("GAAP"). These accounting principles require us to make certain estimates, judgments and assumptions. We believe that the estimates, judgments and assumptions upon which we rely are reasonable based upon information available to us at the time that these estimates, judgments and assumptions are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities as of the date of the financial statements as well as the reported amounts of revenues and expenses during the periods presented. Our financial statements would be affected to the extent there are material differences between these estimates and actual results. In many cases, the accounting treatment of a particular transaction is specifically dictated by GAAP and does not require management's judgment in its application. There are also areas in which management's judgment in selecting any available alternative would not produce a materially different result. The following discussion should be read in conjunction with our unaudited consolidated financial statements and notes thereto appearing elsewhere in this report.
Plan of Operation
Headquartered in Denver, Colorado, MusclePharm is a rapidly expanding healthy life-style company that develops and manufactures a full line of National Sanitation Foundation International and scientifically approved, nutritional supplements that are 100% free of any banned substances. Based on years of research, MusclePharm products are created through an advanced six-stage research protocol involving the expertise of top nutritional scientists and field tested by more than 100 elite professional athletes from various sports including the National Football League, mixed martial arts, and Major League Baseball. The Company's propriety and award winning products address all categories of an active lifestyle including muscle building, weight loss, and maintaining general fitness through a daily nutritional supplement regimen. MusclePharm is sold in over 120 countries and available in over 5,000 U.S. retail outlets, including GNC, Vitamin Shoppe, and Vitamin World. The Company also sells its products in over 100 online stores, including bodybuilding.com, amazon.com and vitacost.com.
Business Strategy
Our primary focus at the current time is on the following:
1. Increase our distribution and sales;
2. Continue aggressive marketing campaign to further build upon our brand and market awareness and recognition;
3. Conduct additional testing of the safety and efficacy of our products; and
4. Hire additional key employees to continue to strengthen the Company.
Results of Operations
For the Six Months Ended June 30, 2011 and 2010 (unaudited):
Six months ended
June 30, June 30,
2011 2010
Sales $ 7,320,580 $ 1,726,697
Gross profit $ 2,514,715 $ 534,089
General and administrative expenses $ (5,495,708 ) $ (5,661,122 )
Loss from operations $ (2,980,993 ) $ (5,127,033 )
Other expenses $ (9,467,552 ) $ (674,343 )
Net Loss $ (12,448,545 ) $ (5,801,376 )
Net loss per common share - basic and diluted $ (0.07 ) $ (0.21 )
Sales
Sales were $7,320,580 for the six months ended June 30, 2011, as compared to $1,726,697 for the comparable six months ended June 30, 2010. The significant increase in sales was primarily attributable to increased brand awareness. Since inception, the Company has focused on an aggressive marketing plan to penetrate the market. As a direct result of the aggressive marketing plan, our products are currently being offered in more retail stores, both domestic and international, and our products are receiving better shelf placement.
Gross Profit
Gross profit percentage strengthened from 30% during the six months ended June 30, 2010, to 34% during the six months ended June 30, 2011. The increase in the gross profit percentage is primarily attributable to the Company's ability to negotiate more favorable terms due to the increased volume in product sales.
General and Administrative Expenses
General and administrative expenses for the six months ended June 30, 2011, were $5,495,708, as compared to $5,661,122 for the comparable six months ended June 30, 2010. The $165,414 decrease is attributable to a substantial decrease in stock based compensation of $2,011,364. The major decrease in stock based compensation was offset by an increase in employee compensation. The Company's employee headcount increased from 12 employees during the six months ended June 30, 2010, to 16 employees during the six months ended June 30, 2011. In addition, the Company experienced significant growth, and as a direct result, general overhead has increased.
Loss from Operations
Loss from operations for the six months ended June 30, 2011, was $2,980,993 as compared to $5,127,033 for the comparable six months ended June 30, 2010. The decrease in operating loss is primarily attributable to the aggressive marketing plan and the Company's ability to gain brand recognition resulting in increased sales during the six months ended June 30, 2011 as compared to the six months ended June 30, 2010.
Other expenses
Other expenses for the six months ended June 30, 2011, were $9,467,552, as compared to $674,343 for the comparable six months ended June 30, 2010. The increase in other expenses of $8,793,209 is primarily attributable to the financing transactions the Company entered into during the six months ended June 30, 2011. The Company issued $3,753,733 in convertible notes during the six months ended June 30, 2011. These notes bore interest at rates ranging from 6% to 12% per annum. Interest expense during the six months ended June 30, 2011, increased $2,828,047 as compared to the comparable six months ended June 30, 2010. In addition, the convertible notes contained embedded derivatives, due to the Company not being able to determine the number of shares needed to settle the conversion priveledge. As a result, on the commitment date of each financing, the Company recorded an aggregate derivative expenses of $4,057,859 and on the date of remeasurement, which is June 30, 2011, a change in fair market value of $634,770. There were no derivative liabilities recorded as of June 30, 2010.
The Company also issued shares of the Company's common stock to satisfy aged accounts payable, accrued expenses and debt. The Company recorded a loss on settlement in the amount of $2,542,073 as a result of these transactions.
Net Loss
Net loss for the six months ended June 30, 2011, was $12,448,545 or loss per share of $(0.07), as compared to $5,801,376 or loss per share of $(0.21) for the comparable six months ended June 30, 2010.
Inflation did not have a material impact on the Company's operations for the period. Other than the foregoing, management knows of no trends, demands, or uncertainties that are reasonably likely to have a material impact on the Company's results of operations.
For the Three Months Ended June 30, 2011 and 2010 (unaudited):
Three months ended
June 30, June 30,
2011 2010
Sales $ 3,802,806 $ 468,109
Gross profit $ 1,321,149 $ 106,859
General and administrative expenses $ (3,214,917 ) $ (2,982,236 )
Loss from operations $ (1,893,768 ) $ (2,875,377 )
Other expenses $ (5,542,854 ) $ (316,283 )
Net Loss $ (7,436,623 ) $ (3,191,660 )
Net loss per common share - basic and diluted $ (0.04 ) $ (0.11 )
Sales
Sales were $3,802,806 for the three months ended June 30, 2011, as compared to $468,109 for the comparable three months ended June 30, 2010. The significant increase in sales was primarily attributable to increased brand awareness. Since inception, the Company has focused on an aggressive marketing plan to penetrate the market. As a direct result of the aggressive marketing plan, our products are currently being offered in more retail stores, both domestic and international, and our products are receiving better shelf placement.
Gross Profit
Gross profit percentage strengthened from 23% during the three months ended June 30, 2010 to 35% during the three months ended June 30, 2011. The increase in the gross profit percentage is primarily attributable to the Company's ability to negotiate more favorable terms due to the increased volume in product sales.
General and Administrative Expenses
General and administrative expenses for the three months ended June 30, 2011, were $3,214,917, as compared to $2,982,236 for the comparable three months ended June 30, 2010. The $232,681 increase is attributable to a a slight increase in employee compensation. The Company's employee headcount increased from 12 employees during the three months ended June 30, 2010, to 15 employees during the three months ended June 30, 2011. In addition, due to the Company experience in growth in sales, expenses have increased accordingly.
Loss from Operations
Loss from operations for the three months ended June 30, 2011, was $1,893,768 as compared to $2,875,377 for the comparable three months ended June 30, 2010. The decrease in operating loss is primarily attributable to the aggressive marketing plan and the Company's ability to gain brand recognition resulting in increased sales during the three months ended June 30, 2011 as compared to the three months ended June 30, 2010.
Other expenses
Other expenses for the three months ended June 30, 2011, were $5,542,854, as compared to $316,283 for the comparable three months ended June 30, 2010. The increase in other expenses of $5,226,571 is primarily attributable to features associated with the financing transactions the Company entered into during the three months ended June 30, 2011. Interest expense during the three months ended June 30, 2011, increased approximately $2,667,185 as compared to the comparable three months ended June 30, 2010. In addition, the convertible notes contained embedded derivatives, due to the Company not being able to determine the number of shares needed to settle the conversion priviledge. As a result, on the commitment date of each financing, the Company recorded an aggregate derivative expenses of $2,698,490 and on the date of remeasurement, which is June 30, 2011, a change in fair market value of $766,487. There were no derivative liabilities recorded for the three months ended June 30, 2010.
The Company also issued shares of the Company's common stock to satisfy aged accounts payable, accrued expenses and debt. The Company recorded a loss on settlement in the amount of $627,384 as a result of these transactions.
Net Loss
Net loss for the three months ended June 30, 2011, was $7,436,623 or loss per share of $(0.03), as compared to $3,191,660 or loss per share of $(0.11) for the comparable three months ended June 30, 2010.
Inflation did not have a material impact on the Company's operations for the period. Other than the foregoing, management knows of no trends, demands, or uncertainties that are reasonably likely to have a material impact on the Company's results of operations.
Liquidity and Capital Resources
The following table summarizes total current assets, liabilities and working
capital at June 30, 2011 compared to December 31, 2010.
June 30,
2011 December 31,
(unaudited) 2010 Increase/Decrease
Current Assets $ 3,308,665 $ 1,406,310 $ 1,902,355
Current Liabilities $ 10,346,583 $ 4,215,649 $ 6,130,934
Working Capital (Deficit) $ (7,037,918 ) $ (2,809,339 ) $ (4,228,579 )
As June 30, 2011, we had a working capital deficit of $7,037,918, as compared to a working capital deficit of $2,809,339, at December 31, 2010, a decrease of $(4,228,579). The decrease is primarily attributable to the Company issuing $3,735,733 in convertible notes during the six months ended June 30, 2011. The Company continues to devote significant resources to continue aggressively market the product line.
Net cash used for operating activities for the six months ended June 30, 2011 and 2010 was $(2,645,448) and $(1,527,797), respectively. The net loss for the six months ended June 30, 2011 and 2010 was $(12,448,545) and $(5,801,376), respectively.
Net cash used for investing activities for the six months ended June 30, 2011 and 2010 was $(324,435) and $(6,884), respectively. The Company purchased gym and office equipment during the six months ended June 30, 2011.
Net cash obtained through all financing activities for the six months ended June 30, 2011 was $3,443,990, as compared to $1,534,681 for the six months ended June 30, 2010.
Going Concern
As reflected in the accompanying unaudited interim consolidated financial statements, the Company had a net loss of $12,448,545 and net cash used in operations of $2,645,448 for the six months ended June 30, 2011, and a working capital deficit and stockholders' deficit of $7,037,918 and $5,561,132, respectively, at June 30, 2011. These factors raise substantial doubt about the Company's ability to continue as a going concern.
The ability of the Company to continue its operations is dependent on management's plans, which include the raising of capital through debt and/or equity markets with some additional funding from other traditional financing sources, including term notes, sale of aged debt to third parties in exchange for free trading stock, until such time that funds provided by operations are sufficient to fund working capital requirements. The Company may need to incur liabilities with certain related parties to sustain the Company's existence.
The Company will require additional funding to finance the growth of its current and expected future operations as well as to achieve its strategic objectives. The Company believes its current available cash along with anticipated revenues may be insufficient to meet its cash needs for the near future. There can be no assurance that financing will be available in amounts or terms acceptable to the Company, if at all.
In response to these problems, management has taken the following actions:
? seeking additional third party debt and/or equity financing;
? continue with the implementation of the business plan;
? generate new sales from international customers; and
? allocate sufficient resources to continue with advertising and marketing efforts.
Financings
Our primary source of operating cash has been through the sale of equity and through the issuance of convertible secured promissory notes.
The Company continues to explore potential expansion opportunities in the industry in order to boost sales, while leveraging distribution systems to consolidate lower costs. The Company needs to continue to raise money in order execute the business plan.
Off-Balance Sheet Arrangements
Other than the operating leases, as of June 30, 2011, the Company did not have any off-balance sheet arrangements.
We are obligated under an operating lease for the rental of office space. Future minimum rental commitments with a remaining term in excess of one year as of June 30, 2011 are as follows:
PERIODS ENDING DECEMBER 31,
2011 $ 40,152
2012 87,560
2013 93,448
2014 99,576
2015 105,704
Total minimum lease payments $ 426,439
Critical Accounting Policies
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions. These estimates and assumptions affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reported period. Actual results could differ materially from those estimates. The Company believes the following accounting policies are critical to the judgments and estimates used in the preparation of its financial statements:
Accounts Receivable and Allowance for Doubtful Accounts
Accounts receivable represents trade obligations from customers that are subject to normal trade collection terms. The Company periodically evaluates the collectability of its accounts receivable and considers the need to establish an allowance for doubtful accounts based upon historical collection experience and specific customer information. Accordingly, the actual amounts could vary from the recorded allowances.
The Company does not charge interest on past due receivables. Receivables are determined to be past due based on the payment terms of the original invoices.
Revenue Recognition
The Company records revenue when all of the following have occurred: (1) persuasive evidence of an arrangement exists, (2) product has been shipped or delivered, (3) the sales price to the customer is fixed or determinable, and (4) collectability is reasonably assured.
Depending on individual customer agreements, sales are recognized either upon shipment of products to customers or upon delivery. The Company records sales allowances and discounts as a direct reduction of sales.
Beneficial Conversion Feature
For conventional convertible debt where the rate of conversion is below market value, the Company records a "beneficial conversion feature" ("BCF") and related debt discount.
When the Company records a BCF, the relative fair value of the BCF would be recorded as a debt discount against the face amount of the respective debt instrument. The discount would be amortized to interest expense over the life of the debt.
Derivative Liabilities
Fair value accounting requires bifurcation of embedded derivative instruments such as conversion features in convertible debt or equity instruments, and measurement of their fair value for accounting purposes. In determining the appropriate fair value, the Company uses the Black-Scholes option-pricing model. In assessing the convertible debt instruments, management determines if the convertible debt host instrument is conventional convertible debt and further if there is a beneficial conversion feature requiring measurement. If the instrument is not considered conventional convertible debt, the Company will continue its evaluation process of these instruments as derivative financial instruments.
Once determined, derivative liabilities are adjusted to reflect fair value at each reporting period end, with any increase or decrease in the fair value being recorded in results of operations as an adjustment to fair value of derivatives. In addition, the fair value of freestanding derivative instruments such as warrants, are also valued using the Black-Scholes option-pricing model.
Debt Issue Costs and Debt Discount
The Company may pay debt issue costs, and record debt discounts in connection with raising funds through the issuance of convertible debt. These costs are amortized over the life of the debt to interest expense. If a conversion of the underlying debt occurs, a proportionate share of the unamortized amounts is immediately expensed.
Original Issue Discount
For certain convertible debt issued, the Company provides the debt holder with an original issue discount. The original issue discount is recorded to debt discount and additional paid in capital at an amount not to exceed gross proceeds raised, reducing the face amount of the note and is amortized to interest expense over the life of the debt.
Share-based payments
Generally, all forms of share-based payments, including stock option grants, warrants, restricted stock grants and stock appreciation rights are measured at their fair value on the awards' grant date, based on estimated number of awards that are ultimately expected to vest. Share-based compensation awards issued to non-employees for services rendered are recorded at either the fair value of the services rendered or the fair value of the share-based payment, whichever is more readily determinable.
Recent Accounting Pronouncements
There are no recent accounting pronouncements that are expected to have an effect on the Company's consolidated financial statements.
KBLB Form 10-Q for KRAIG BIOCRAFT LABORATORIES, INC
15-Aug-2011
Quarterly Report
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Caution Regarding Forward-Looking Information
Certain statements contained herein, including, without limitation, statements containing the words "believes," "anticipates," "expects," "plan" and words of similar import, constitute forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.
Such factors include, among others, the following: international, national and local general economic and market conditions: demographic changes; the ability of the Company to sustain, manage or forecast its growth; the ability of the Company to successfully make and integrate acquisitions; raw material costs and availability; new product development and introduction; existing government regulations and changes in, or the failure to comply with, government regulations; adverse publicity; competition; the loss of significant customers or suppliers; fluctuations and difficulty in forecasting operating results; changes in business strategy or development plans; business disruptions; the ability to attract and retain qualified personnel; the ability to develop technology and products; changes in technology and the development of technology and intellectual property by competitors; the ability to protect technology and develop intellectual property; and other factors referenced in this and previous filings.
Given these uncertainties, readers of this filing and investors are cautioned not to place undue reliance on such forward-looking statements.
Plan of Operations
During the next twelve months, we expect to take the following steps in connection with the further development of our business and the implementation of our plan of operations:
? We expect to spend approximately $35,000 per quarter over the next 12 months on collaborative research and development of high strength polymers at the University of Notre Dame. We believe that this research is important to our product development. If our financing will allow, management will give strong consideration to accelerating the pace of spending on research and development within the University of Notre Dame's laboratories.
? We expect to spend approximately $13,700 on collaborative research and development of high strength polymers and spider silk protein at the University of Wyoming over the next twelve months. We believe that this research is important to our product development. This level of research spending at the university is also a requirement of our licensing agreement with the university. If our financing will allow, management will give strong consideration to accelerating the pace of spending on research and development within the University of Wyoming's laboratories.
? We will actively consider pursuing collaborative research opportunities with other university laboratories in the area of high strength polymers. If our financing will allow, management will give strong consideration to increasing the depth of our research to include polymer production technologies that are closely related to our core research
? We will consider buying an established revenue producing company which is operating in the textile arena, in order to broaden our financial base and facilitate the commercialization of our products. We expect to use a combination of stock and cash for any such purchase.
? We will also actively consider pursuing collaborative research opportunities with both private and university laboratories in areas of research which overlap the company's existing research and development. One such potential area for collaborative research which the company is considering is protein expression platforms. If our financing will allow, management will give strong consideration to increasing the breadth of our research to include protein expression platform technologies.
? We plan to actively pursue collaborative product testing, manufacturing and marketing opportunities with companies in the textile industry.
Limited Operating History
We have not previously demonstrated that we will be able to expand our business through an increased investment in our research and development efforts. We cannot guarantee that the research and development efforts described in this filing will be successful. Our business is subject to risks inherent in growing an enterprise, including limited capital resources, risks inherent in the research and development process and possible rejection of our products in development.
If financing is not available on satisfactory terms, we may be unable to continue expanding our operations. Equity financing will result in a dilution to existing shareholders.
Results of Operations
Three and Six Months ended June 30, 2011 and 2010.
Revenue for the three and six months ended June 30, 2011 was $0. This compares to $0 in revenue for the three and six month periods which ended June 30, 2010. The Company has recently announced the development of new recombinant silks. No revenue projections for the next twelve months are being made as these products are new and are not yet on the market.
Operating expenses for the three and six months ended June 30, 2011 were $337,813 and $582,770, respectively. This compares to $130,336 and $411,208 in expenses during the three and six month periods, respectively, which ended June 30, 2010. The primary reason for the increase was an increase in research and development spending. Management anticipates that public relations expense will increase over the next twelve months. Research and development expenses for the three and six months ended June 30, 2011 were $140,850 and $232,693, respectively. This compares to $15,875 and $24,117 spent on research and development during the three and six months ended June 30, 2010, respectively. The increase in research and development spending was the result of the reimbursement nature of our recently expired research agreement with the University of Notre Dame, and Management anticipates that these costs will rise over the next twelve months. In addition, we had the following expenses during the three and six month periods which ended June 30, 2011: general and administrative $141,514 and $224,249, respectively, professional fees $2,949 and $20,828, respectively, officer's salary $52,500 and $105,000, respectively and public relations $0 and $0, respectively. This compares to the same expenses during the three and six month periods which ended June 30, 2010: general and administrative $30,335 and $48,478, respectively, professional fees $20,309 and $25,286, respectively, officer's salary $58,390 and $116,779, respectively and public relations $3,948 and $103,948, respectively.
Capital Resources and Liquidity
As of June 30, 2011 we had $98,496 in cash compared to $7,763 as of June 30, 2010.
We believe we can not satisfy our cash requirements for the next twelve months with our current cash. Completion of our plan of operation is subject to attaining adequate financing. We cannot assure investors that adequate financing will be available. In the absence of such financing, we may be unable to proceed with our plan of operations.
We anticipate that our operational, and general & administrative expenses for the next 12 months will total approximately $750,000. We do not anticipate the purchase or sale of any significant equipment. We also do not expect any significant additions to the number of employees. The foregoing represents our best estimate of our cash needs based on current planning and business conditions. The exact allocation, purposes and timing of any monies raised in subsequent private financings may vary significantly depending upon the exact amount of funds raised and our progress with the execution of our business plan.
In the event we are not successful in obtaining financing, we may not be able to proceed with our business plan for the commercialization of our products and further research and development of new products. We anticipate that we will incur operating losses in the foreseeable future. Therefore, our auditors have raised substantial doubt about our ability to continue as a going concern.
Critical Accounting Policies
Our financial statements and related public financial information are based on the application of accounting principles generally accepted in the United States ("GAAP"). GAAP requires the use of estimates; assumptions, judgments and subjective interpretations of accounting principles that have an impact on the assets, liabilities, revenue and expense amounts reported. These estimates can also affect supplemental information contained in our external disclosures including information regarding contingencies, risk and financial condition. We believe our use of estimates and underlying accounting assumptions adhere to GAAP and are consistently and conservatively applied. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. Actual results may differ materially from these estimates under different assumptions or conditions. We continue to monitor significant estimates made during the preparation of our financial statements.
Our significant accounting policies are summarized in Note 1 of our financial statements. While all these significant accounting policies impact its financial condition and results of operations, we view certain of these policies as critical. Policies determined to be critical are those policies that have the most significant impact on our financial statements and require management to use a greater degree of judgment and estimates. Actual results may differ from those estimates. Our management believes that given current facts and circumstances, it is unlikely that applying any other reasonable judgments or estimate methodologies would cause effect on our results of operations, financial position or liquidity for the periods presented in this report.
Recent Accounting Pronouncements
In May 2011, the FASB issued ASU No. 2011-04, "Fair Value Measurement:
Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in U.S. GAAP and IFRS" ("ASU 2011-04"). ASU 2011-04 defines fair value, clarifies a framework to measure fair value, and requires specific disclosures of fair value measurements. The guidance will be effective for interim and annual reporting periods beginning after January 1, 2012 and is required to be applied retrospectively. The Company does not believe the adoption of ASU 2011-04 will have a material impact on its financial statements.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements, financings, or other relationships with unconsolidated entities or other persons, also known as "special purpose entities" (SPEs).
ITEM 4T. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures.
The Securities and Exchange Commission defines the term "disclosure controls and procedures" to mean controls and other procedures of an issuer that are designed to ensure that information required to be disclosed in the reports that it files or submits under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Securities Exchange Act of 1934 is accumulated and communicated to the issuer's management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. The Company maintains such a system of controls and procedures in an effort to ensure that all information which it is required to disclose in the reports it files under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified under the SEC's rules and forms and that information required to be disclosed is accumulated and communicated to principal executive and principal financial officers to allow timely decisions regarding disclosure.
The Company carried out an evaluation, under the supervision and with the participation of the Company's management, including the Company's Chief Executive Officer ("CEO") and Chief Financial Officer ("CFO") (the Company's principal financial and accounting officer), of the effectiveness of the Company's disclosure controls and procedures as of the end of the period covered by this report. Based upon that evaluation, the Company's CEO and CFO concluded that the Company's disclosure controls and procedures are not effective.
Changes in Internal Control over Financial Reporting.
In order to rectify our ineffective disclosure controls and procedures, we are developing a plan to ensure that all information will be recorded, processed, summarized and reported accurately, and as of the date of this report, we have taken the following steps to address the above-referenced material weaknesses in our internal control over financial reporting:
1. We will continue to educate our management personnel to comply with the disclosure requirements of Securities Exchange Act of 1934 and Regulation S-K; and
2. We will increase management oversight of accounting and reporting functions in the future.
PART II - OTHER INFORMATION
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
On April 1, 2011 the Company issued 1,000,000 shares with a fair value of $70,000 ($0.07/share) to a consultant for research and development services.
On April 18, 2011, the Company issued 1,029,412 shares of stock with a fair value of $70,000 based on the average trading price over a 30 day period for a research and development consulting agreement.
On April 22, 2011 the Company issued 1,420,455 shares of common stock for $100,000 ($0.07/share).
On May 11, 2011, the Company issued 19,767,985 shares in connection with the cashless exercise of the 20,000,000 warrants.
The foregoing issuances of the shares were effectuated pursuant to the exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), provided by Section 4(2) of the Securities Act and/or Regulation D promulgated thereunder.
ITEM 6. EXHIBITS
(a) Exhibits
31.1 Certifications by the Chief Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) under the Securities Exchange Act of 1934, as amended, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1 Certifications by the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101 Interactive Data Files.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
KRAIG BIOCRAFT LABORATORIES, INC.
Date: August 15, 2011 By: /s/ Kim Thompson Kim Thompson
Chief Executive Officer and Chief Financial Officer
Form 8-K for GENVEC INC
12-Aug-2011
Entry into a Material Definitive Agreement, Material Modification to Rights of Securit
Item 1.01 - Entry into a Material Definitive Agreement
On August 11, 2011, GenVec, Inc. (the "Company") entered into a Rights Agreement (the "Rights Agreement") between the Company and American Stock Transfer & Trust Company, LLC, as Rights Agent (the "Rights Agent"). The Company entered into the Rights Agreement in connection with the expiration of the Company's current rights agreement, which is scheduled to expire on September 7, 2011.
In connection with entering into the Rights Agreement, on August 11, 2011 the Board of Directors of the Company declared a distribution of one Right (a "Right") for each outstanding share of Common Stock, $0.001 par value per share (the "Common Stock"), to stockholders of record at the close of business on September 7, 2011, (the "Record Date") and for each share of Common Stock issued (including shares distributed from Treasury) by the Company thereafter and prior to the Distribution Date (as described below and defined in the Rights Agreement). Each Right entitles the registered holder, subject to the terms of the Rights Agreement (as defined below), to purchase from the Company one one-thousandth of a share of Series B Junior Participating Preferred Stock, $0.001 par value per share (the "Preferred Stock"), at a Purchase Price of $32.00 per one one-thousandth of a share of Preferred Stock, subject to adjustment (the "Purchase Price"). The description and terms of the Rights are set forth in the Rights Agreement.
The Rights Agreement
Initially, no separate Rights Certificates will be distributed and instead the Rights will attach to all certificates representing shares of outstanding Common Stock, or, with respect to Common Stock in Book Entry form, to the outstanding shares of Common Stock evidenced by the balances indicated in the Book Entry account system of the transfer agent for the Common Stock. The Rights will separate from the Common Stock and the "Distribution Date" will occur upon the earlier of (i) ten Business Days following a public announcement that a person or group of affiliated or associated persons has become an "Acquiring Person," or (ii) ten Business Days (or such later date as may be determined by the Board of Directors prior to such time as any person becomes an Acquiring Person) following the commencement of a tender offer or exchange offer that would result in a person or group of affiliated and associated persons beneficially owning 20% or more of the shares of Common Stock then outstanding. Until the Distribution Date, (i) the Rights will be evidenced by the balances indicated in the Book Entry account system of the transfer agent for the Common Stock registered in the names of the holders thereof or, in the case of certificated shares, by Common Stock certificates, and will be transferred with and only with such underlying shares of Common Stock, (ii) confirmation and account statements sent to holders of Common Stock in Book Entry form or, in the case of certificated shares, certificates, representing such shares of Common Stock, issued after the Record Date (including shares distributed from Treasury) will contain a notation incorporating the Rights Agreement by reference, and (iii) the transfer of any shares of outstanding Common Stock will also constitute the transfer of the Rights associated with such shares of Common Stock.
As used in the Rights Agreement, an "Acquiring Person" means a person or group of affiliated or associated persons that has acquired, obtained the right to acquire, or otherwise obtained beneficial ownership of 20% or more of the shares of Common Stock then outstanding. The following, however, are not Acquiring Persons: the Company, its subsidiaries, any employee benefit plan of the Company or any of its subsidiaries, or any entity holding shares of Common Stock pursuant to the terms of any such plan. Moreover, no person or affiliated persons will be deemed to be an Acquiring Person as a result of the following: (1) an acquisition of Common Stock by the Company, which, by reducing the number of shares of Common Stock outstanding, increases the percentage of the shares of Common Stock that such person, or group of affiliated or associated persons, beneficially owns to 20% or more of the shares of Common Stock then outstanding, (2) any unilateral grant of any security by the Company to such person, (3) through the exercise of any options, warrants, rights or similar interests (including restricted stock) granted by the Company to its directors, officers and employees or (4) being the beneficial owner of 20% or more of the shares of Common Stock then outstanding as of the date of the Rights Agreement or prior to the first public announcement of the adoption of the Rights Agreement.
Notwithstanding the foregoing, a person, or group of affiliated or associated persons, who would be considered an Acquiring Person but for the exceptions in
(1) through (4) in the prior sentence, will nonetheless be considered an Acquiring Person if such person, or group of affiliated or associated persons, continues to hold 20% or more of the shares of Common Stock outstanding and becomes the beneficial owner of additional shares of Common Stock, subject to certain exceptions described in the Rights Agreement. Moreover, if the Board of Directors of the Company determines that a person, or group of affiliated or associated persons, who would otherwise be an Acquiring Person, has become so inadvertently (either because such person, or group of persons, was unaware that it beneficially owned the requisite percentage of outstanding Common Stock or because it had no actual knowledge of the consequences of such beneficial ownership under the Rights Agreement), and such person, or group of affiliated or associated persons, promptly divests a sufficient number of shares of Common Stock so that it would no longer be an Acquiring Person, then such person or group of affiliated or associated persons shall not be deemed to be or to have become an Acquiring Person for any purposes of the Rights Agreement.
The Rights are not exercisable until the Distribution Date and will expire at the close of business on September 7, 2021 unless earlier redeemed or exchanged by the Company as described below.
As soon as practicable after the Distribution Date, Rights Certificates will be mailed to holders of record of Common Stock as of the close of business on the Distribution Date and, thereafter, the separate Rights Certificates alone will represent the Rights.
In the event that a person or group of affiliated or associated persons becomes an Acquiring Person, then each holder of a Right will thereafter have the right to receive, upon exercise, shares of Common Stock (or, in certain circumstances, shares of Preferred Stock, other securities, cash, property, or a combination thereof) having a value equal to two times the exercise price of the Right. The exercise price is the Purchase Price multiplied by the number of one . . .
Item 3.03 - Material Modification to Rights of Security Holders
The information contained in Item 1.01, which includes information on the Rights and the Rights Agreement, is incorporated herein by reference.
Item 5.03 - Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year
On August 11, 2011, the Company filed a Certificate of Designation of Series B Junior Participating Preferred Stock (the "Certificate of Designation") with the Secretary of State of Delaware. In connection with the adoption of the Certificate of Designation, the Board of Directors of the Company authorized the creation of a Series of 30,000 shares of Series B Junior Participating Preferred Stock. A copy of the Certificate of Designation is attached hereto as Exhibit 3.1 and is incorporated herein by reference.
Item 9.01 - Financial Statements and Exhibits
(d) Exhibits
3.1 Certificate of Designation of Series B Junior Participating
Preferred Stock
4.1 Rights Agreement, dated as of August 11, 2011, by and between
GenVec, Inc. and American Stock Transfer & Trust Company, LLC, as
Rights Agent
99.1 Press Release dated August 11, 2011
GNVC 10:56AM GenVec renews stockholder rights plan (GNVC)
has approved the replacement of its Stockholder Rights Plan through the adoption of a new Rights Agreement. The new Stockholder Rights Plan is to become effective on September 7, 2011, which is the date that GenVec's existing Rights Agreement is set to expire.
http://finance.yahoo.com/marketupdate/inplay#gnvc
GNVC GenVec narrows loss on higher revenue
Washington Business Journal
Date: Tuesday, August 9, 2011, 11:28am EDT
Gaithersburg-based GenVec Inc. narrowed its loss in its latest quarter as expenses declined and revenue rose.
GenVec, which develops vaccines and therapeutic drugs, reported a net loss of $1.2 million, or 10 cents per share, in the second quarter of 2011. That compares with a net loss of $4.2 million, 33 cents per share, in the year-ago quarter.
GenVec reduced operating expenses by almost 19 percent in the latest quarter to $6 million from $7.4 million a year ago due to lower clinical costs and some lower professional expenses.
Revenue in the latest quarter rose 47 percent to $4.7 million from $3.2 million a year due to increased revenue from Novartis for a hearing program.
GenVec said its quarterly highlights included regaining its NASDAQ listing compliance and expanding its partnership with Merial, the animal health division of sanofi-aventis.
GenVec (NASDAQ: GNVC) ended the second quarter with $30.6 million in cash in the bank.
The company expects its cash burn to be between $6 million and $8 million for the 12months ending June 30, 2012, and for it to realize revenues of between $20 million and $22 million in 2011.
KBLB Kraig Biocraft Laboratories Completes Scheduled Second Round of Micro Insertions Using Zinc Finger Technology
Kraig Advances Zinc Finger Technology to Modify Previously Disclosed Monster Silk
Press Release Source: Kraig Biocraft Laboratories, Inc. On Monday August 8, 2011, 6:05 am EDT
LANSING, MI--(Marketwire -08/08/11)- Kraig Biocraft Laboratories, Inc. (Pinksheets: KBLB.PK - News) announced that researchers working with the Company recently completed the second round of micro-insertions using zinc finger technology. The use of the zinc finger technology in the second round is designed to further enhance Kraig's previously disclosed Monster Silk polymers.
"This round of micro-insertions is focused on further modifying and advancing the capabilities of our 'Monster Silk' caterpillars," said CEO Kim Thompson. "In the second round, the zinc finger technology is being used to modify one of the company's transgenic lines of silk worm that are already producing recombinant spider silk. This work represents a significant step forward from our first round of zinc finger micro-insertions.
"We are so confident in the technology," continued Thompson, "that we advanced to the second round of micro-insertions even while we are still awaiting a definitive report on the first round."
The current second round is focused on two objectives: 1) modifying the profile of the expressed proteins in the previously disclosed "Monster Silk" fiber, and 2) potentially creating a new recombinant silk platform technology.
"We are very happy to see this work progressing so quickly," said Thompson. "As I have previously noted, we are monitoring the results of round one, and now of round two, very closely. We are very optimistic that we will be able to announce results from the first round in early Fall, and results from the second round, in approximately the middle to late Fall."
MMTE Mammoth Energy Group on Acquisition Hunt
Press Release Source: Mammoth Energy Group, Inc. On Friday August 5, 2011, 1:05 pm EDT
NEW YORK, NY--(Marketwire -08/05/11)- Mammoth Energy Group Inc. (Pinksheets: MMTE.PK - News), a lithium and alternative energy mining company, announced today that its wholly owned subsidiary Compania Lithium Investments Limitada of Chile is currently on an acquisition hunt for additional lithium projects in Argentina and Chile.
"We are currently speaking to three other groups with additional concessions located in Argentina and Chile and expect that we will be able to move forward with more information in the future as discussions move along," said William Lieberman, President of Mammoth Energy Group.
Mammoth Energy Group's Compania Lithium Investments Limitada has already acquired an initial thirteen lithium concessions for a total of 8649 acres (3500 Hectares) in the southern section of the Salar de Maricunga, seven concessions for a total of 4695 acres (1900 hectares) in the Salar de Pujsa, and now with the 2471 acres (1000 hectares) in the Salar del Laco for a total of just under 16,000 combined acres throughout Chile. The company is currently in acquisition mode and Compania Lithium Investments Limitada was created to acquire, develop and explore lithium and mining assets in Chile on behalf of Mammoth Energy Group Inc.
GNVC GenVec to Release Second Quarter 2011 Financial Results and Conduct a Conference Call on August 9, 2011
GAITHERSBURG, Md., Aug. 2, 2011 /PRNewswire/ -- GenVec, Inc. (Nasdaq:GNVC - News) will report financial results for the second quarter of 2011 on Tuesday, August 9, 2011, before the U.S. financial markets open. The announcement will be followed by a webcast and conference call at 10:00 a.m. EDT to discuss the company's second quarter financial results and business outlook.
To listen to the live conference call, please dial 877-558-0567 (U.S. or Canada) or 706-643-4980 (international) and use the following Conference ID: 84527868. An audio replay of the conference call will be available starting at 1:00 p.m. EDT on August 9, 2011 through August 16, 2011. To listen to the audio replay, dial 855-859-2056 or 404-537-3406 and use Conference Replay ID: 84527868.
To access the webcast or the replay, go to www.genvec.com, click on "Investors and Media," and click on "Events and Presentations."
MusclePharm Announces Preliminary Second Quarter 2011 Results
DENVER, July 14, 2011 /PRNewswire/ -- MusclePharm Corporation, a Nevada corporation ("MusclePharm" or the "Company") (OTCBB:MSLP.ob - News), an expanding U.S. nutritional supplement company, is pleased to announce MusclePharm's preliminary financial results for the first quarter ended June 30, 2011.
On a preliminary basis, the Company expects unaudited gross revenues for the three months ended June 30, 2011 of approximately $4,000,000, an increase of approximately 854% as compared to gross revenues of $468,109 during the corresponding three month period ended June 30, 2010.
Gross Margins for the first quarter of 2011 are expected to have increased to approximately 35%, or $1,320,000, as compared to gross margins of approximately 23%, or $106,859, in the second quarter of 2010.
Commenting on the preliminary results, Brad Pyatt, Chief Executive Officer said, "We are very pleased with the 854% revenue growth and over 10% margin improvement we experienced during the second quarter of 2011. Our expanding product line, combined with the rapidly growing online and retail distribution business, has us well positioned for continued future growth."
Mr. Pyatt continued, "The growth of our brand recognition that we have built in less than 3 years is a direct result of our aggressive yet calculated marketing model. This approach has allowed us in 2011 to decrease our advertising costs while growing our revenues over 800%."
The Company expects to report a net loss for the three months ended June 30, 2011, but is continually making the necessary changes to become profitable in the near future.
Good morning harr...hopefully MLXO starts kickin' it into gear soon.
JULY 7, 2011 How to Profit From Drug Stocks
Patent expirations and new-drug approvals could alter drug companies' fortunes in the next decade.
By ANDREW BARY
Coming patent expirations on key drugs and the development and marketing of products now in the pharmaceutical industry's pipeline could alter company revenue and profits significantly in coming years. As a result, drug-stock investors are focused not only on this year's earnings but also on those in the distant future.
Mindful of the long-term view, Tim Anderson, an industry analyst at Sanford Bernstein, recently projected 2015 and 2020 profits for nine major U.S. and European drug companies in a report titled "The Long View: Is There Light at the End of the Pharmaceutical 'Patent Cliff' Tunnel?" Few analysts in any industry make such long-term projections.
Anderson's conclusion, based on admittedly subjective assumptions about new-drug revenue, is that GlaxoSmithKline (GSK: 43.80, 0.21, 0.48%), Novartis (NVS: 61.75, 0.17, 0.28%), Pfizer (PFE: 20.34, -0.44, -2.12%), Merck (MRK: 35.92, 0.39, 1.10%), Sanofi-Aventis (SNY: 39.74, -0.34, -0.85%) and Roche Holdings (ROG.VX: , , ) are best positioned long-term, while Eli Lilly (LLY: 37.83, 0.17, 0.45%), Bristol-Myers Squibb (BMY: 29.38, 0.16, 0.55%) and AstraZeneca (AZN: 50.61, 0.25, 0.50%) have a weaker outlook.
The firms likely to have the biggest earnings gains also could be stock-market winners, while those with disappointing profits might be losers. Anderson is most bullish on Novartis, Merck and Pfizer and favorable toward Glaxo, although he rates it Market Perform.
There isn't much variation in the price/earnings ratios of major drug stocks, based on estimated 2011 profits. That means investors can buy companies with sharply rising earnings at only a modest premium to those whose earnings are likely to decline. The six would-be winners in the table below generally have lower price/earnings ratios than the losers, based on projected 2015 profits. All the winners have lower P/Es, based on Anderson's 2020 estimates.
"AstraZeneca and Lilly are in a tough place in the next few years" owing to large revenue losses from expiring patents of important drugs, Anderson says. "Novartis and Glaxo are two of the best-looking companies, and they are among the most diversified."
Novartis, whose U.S.-listed shares trade around 61, may post a 2020 profit of $7.67 a share, up from $5.50 in 2011, while Glaxo, whose stock fetches about 43, could generate earnings of $6 a share in 2020, up from the $3.70 estimated for this year.
A key industry problem and the reason for depressed P/Es throughout the sector is that the revenue potential of new drugs isn't expected to match current sales of Lipitor and other blockbusters set to lose patent protection in coming years. After such protection is lost, revenue from a drug can quickly drop by 75% or more, as patients switch to cheaper generic products. Despite $60 billion in research and development spending last year among the the nine companies listed, the Food and Drug Administration has been approving only about 20 new drugs a year.
Barron's wrote favorably about the industry a year ago ("Wonder Drugs," June 28, 2010), and our then-top picks Merck, Pfizer and Sanofi are up an average of 23% since then, ahead of gains of 19% for the industry and 22% for the S&P 500. One attraction for investors is drug-company dividends; the stocks yield more than 4%, on average.
ANDERSON FAVORS NOVARTIS AND GLAXO, in part because of their sizable nonbranded-drug operations. Novartis owns Alcon, the eye-care giant, and controls Sandoz, the world's No. 2 generic-drug maker, behind Teva Pharmaceutical Industries (TEVA: 49.27, 0.28, 0.57%). This should help Novartis, as more complex drugs known as biologics become subject to generic competition.
Glaxo has a large consumer-products franchise, including Tums, Polident, Aquafresh and Nicorette gum, that kicks in about 20% of revenue. It is also one of three leading vaccine makers, along with Merck and Sanofi. Vaccines offer an annuity-like business model because generic competition is virtually nil due to the difficulty of gaining regulatory approvals.
Pfizer is the industry's main restructuring play as the company weighs sales or spinoffs of its consumer-products and animal-health businesses. Some have speculated that it might even spin off a portfolio of drugs, including Lipitor, that face looming patent expiration. Exiting from this so-called established-products business would reduce revenue by 50%, to $35 billion to $40 billion, giving new products, such as a treatment for rheumatoid arthritis, a bigger financial impact.
A year ago, Pfizer was the industry's most out-of-favor stock, but it since has rallied 40%, to a recent 20.60, as investors have grown more confident that the company can weather a coming string of patent expirations without a profit collapse. Anderson sees upside to 24 if the restructuring plays out and the company has some pipeline success. Merck has been hurt by some pipeline setbacks, but could benefit from its 2009 merger with Schering-Plough and fewer patent expirations than its rivals.
Sanofi is controversial because its CEO, Chris Viehbacher, is dismissive of stock buybacks and spent $20 billion earlier this year to purchase biotech-drug maker Genzyme when Sanofi's shares were trading for seven times earnings. Sanofi has a strong franchise in vaccines and diabetes and cancer drugs, as well as one of the best positions in the emerging markets. After 2012, when Plavix comes off patent in the U.S., Sanofi has no major patent expirations. At 40 a share, it trades for eight times its estimated 2011 profit and seven times projected 2020 earnings.
ROCHE IS THE WORLD'S TOP biotech company following its 2009 purchase of Genentech. It is also a leader in diagnostics, including in-vitro procedures. Its P/E ratio has contracted sharply in recent years, despite a still-strong growth outlook. Its U.S.-listed shares fetch 42, or 11 times estimated 2011 profit and eight times estimated 2015 and 2020 profits.
Bristol-Myers arguably is the industry's R&D champ. It has shed businesses outside of prescription drugs and aims to create a "string of pearls" involving new drugs. The strategy looks smart, given the likely approval of a promising drug for malignant melanoma with more than $1 billion in annual sales potential, and other possible winners. Bristol's success, however, seems reflected in its stock, which trades for 29, or 13 times estimated 2011 profit. Anderson sees no earnings growth in the next decade, as patent expirations on products like Plavix (shared with Sanofi) offset the impact of new ones.
Eli Lilly and AstraZeneca face major patent expirations in the next five years. Lilly's earnings could drop to $3 a share in 2015 and $2 in 2020 from an estimated $4.28 this year. The company's lush dividend yield of 5% might not be sustainable, long-term.
Earnings growth is the best prescription for drug firms. On that score, Novartis, Glaxo, Roche, Pfizer, Sanofi and Merck should be the companies in investors' medicine cabinets.
http://www.smartmoney.com/invest/stocks/how-to-profit-from-drug-stocks-1310058792652/
LOOKING FOR AN INVESTMENT IDEA?
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Kylegirl: NNBP.PK (posted 02.03.11) investorshub.advfn.com/boards/read_msg.aspx
Nanobac Pharmaceuticals: No website at this time. "VERY HIGH RISK, SPECULATIVE STOCK".
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Kylegirl: ILNS.PK (posted 02.05.11) investorshub.advfn.com/boards/read_msg.aspx "VERY HIGH RISK, SPECULATIVE STOCK".
Intellect Neurosciences, Inc.: www.intellectns.com/
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19klongbow: MSLP.OB (posted 02.03.11) investorshub.advfn.com/boards/read_msg.aspx
MusclePharm® Corporation: musclepharm.com/
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19klongbow: MLXO, (KBLB.PK) MSLP (posted 02.03.11) investorshub.advfn.com/boards/read_msg.aspx
Kraig Biocraft Laboratories, Inc.: kraiglabs.com/index.html
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dinotori: GNVC (posted 02.04.11) investorshub.advfn.com/boards/read_msg.aspx
GenVec, Inc.: www.genvec.com/
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Rawnoc: REPR.OB (posted 02.08.11) investorshub.advfn.com/boards/read_msg.aspx
Repro-Med Systems, Inc.: www.rmsmedicalproducts.com/index.htm
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U.S. Securities and Exchange Commission:
sec.gov/edgar/searchedgar/companysearch.html
U.S. Food and Drug Administration: www.fda.gov/
National Drug Code Directory: www.accessdata.fda.gov/scripts/cder/ndc/default.cfm
Drug Firm Annual Registration Status: www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/ucm070998.htm
Biotech Links and Resources: www.biotechnology-stocks.com/link.cfm
BioMedReports.com: biomedreports.com/
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