Showing posts with label VRUS. Show all posts
Showing posts with label VRUS. Show all posts

Thursday, March 1, 2012

Time to Watch BioLargo (OTCBB: BGLO) Go Cash Flow Positive

Time to Watch BioLargo (OTCBB: BGLO) Go Cash Flow PositiveAustin, TX 3/1/12 (StreetBeat) -- Everybody in the investment world has a “shoulda, woulda, coulda”-type of story about an Apple, Inc. (NASDAQ:AAPL) investment opportunity that slipped by them. After all, shares of Apple could have been bought for under $4 each back in 1997. Pharmasset (NASDAQ:VRUS) was around $3 a share just four years ago, before it spiked to $160, did a 2 for 1 forward split back down to $80 and then got acquired by Gilead Sciences (NASDAQ:GILD) for $137 a share to nearly double again for its shareholders a few months ago.

Obviously, those are clearly extreme examples, but there are countless others that produced gains like Force Protection, Inc. that was a bulletin board play trading under a dollar that moved to the Nasdaq and rose exponentially. FRPT peaked at over $30 in just over a year from its lows before sliding back to around $5.00 and getting bought by General Dynamics last year. Solid companies with disruptive technologies, marketing agreements and distribution points can truly be game changers that impact the world and, as it may be, the life of a shareholder.

It does take a close examination of a company to discern what it really has to offer and just how big the company could go. Ask any CEO and you will rarely hear that the company isn’t going to be huge, so it is up to investors to perform their own due diligence and drill-down on the true potential.

Searching for companies with disruptive technologies that can provide viable solutions across multiple verticals brings BioLargo®, Inc. (OTCBB:BLGO) into the lens. The creator of patented iodine technologies, that delivers “Nature’s Best Solution®” – free iodine – to an array of problems, including odor and moisture control, disinfection, and contaminated water, BioLargo’s technology could be used in a multitude of industries that spans from household brand makers like Clorox Company (NYSE:CLX) and Colgate Palmolive (NYSE:CL) to energy giants like Suncor Energy (NYSE:SU) to Pepsico (NYSE:PEP) to premium pet product maker Central Garden & Pet Company (NASDAQ: CENT) and back again. In fact, the U.S.’s largest purveyor of pet products, Central Garden, has already recognized the value of BioLargo’s assets and signed an exclusive agreement to feature BioLargo technology in its product offerings.

Scrolling deeper in the examination of BioLargo leads to SEC filings that brought about questions that needed answered in order for a thorough evaluation.

For starters, when is the Central Garden agreement going to start generating revenue and how much cash will hit BioLargo coffers as a result? It seems assured that the deal will go, but it cannot be distinguished exactly when. With no definitive answers, the situation caters to the particular strategy of an investor as some prefer building a position in anticipation of the revenue and others favor waiting until cash is booked. How much? Per the standard, no guidance is issued, but the technology clearly has exponential uses and the agreement already signed with Central Garden calls for minimum performance thresholds that come due in the next twelve months in order for them to hang onto their exclusive rights. Consider; the cat litter product segment alone is nearly $2 billion per year, with environmentally-safe cat litter that eliminates all odor and as confirmed in side by side testing, out-performs all the competition, (which fits BioLargo’s offerings). This comprises only a small segment of the massive pet products industry estimated to exceed $50 billion annually according to the American Pet Products Association. Based on the minimum purchases stipulated in the executed agreement and average prices from competitors, the deal should net between $3.5 and $5 million per year for BioLargo on the low end. However, given the accolades awarded to BioLargo’s “Odor-No-More®” product, including a 2010 “Product of the Year” award by the Horse Journal for its animal bedding product, and the recent introduction of its Nature’s Best Solution- free iodine wash products for odor and stain removal, which most certainly fit nicely within the pet product category and Central Garden’s industry leading position, then, leaning towards the low end of expectations may be the safe bet, but quite possibly a low-evaluation of much larger potential as multiple products find their way to market with Central.

This license agreement with Central Garden is the first of its type for BioLargo, and alone it could take the company to profitability.

In the company’s filings, there is one glaring statement that could make investors shudder: “current assets of $270,757 and an accumulated stockholders’ deficit of $66,554,899.” These figures could be intimidating unless a proper analysis is conducted to see how the deficit was derived and what it really means. Biolargo, Inc. was essentially a different business before 2007 when it acquired the BioLargo Technology from IOWC, Inc. and also secured the ongoing services (and inventions) of its inventor (Kenneth Reay Code), both joining the team through a reverse merger and recapitalization transaction. The corporate entity, know known as BioLargo, Inc., had a long history dating back to an original incorporation in 1989 and a series of name changes and business endeavors before becoming BioLargo as it is known today.

Not a true representation of BioLargo today or its lean business model over the last five years, its deficit on the books includes all of the operating history of the previous companies dating back to 1991, the $12 + million that was paid for the technology through the issuance of stock, and, capital raises of about $10 million (at an average of 50 cents per share) to get to the point it is at today. A more accurate reflection of the cash deficit of BioLargo is the approximately $10 million that the company has invested over its five years in operations and development costs as the company is now nearing generating meaningful revenue.

Peeling-back the onion further, the filings show that the company has taken write-downs that will benefit current and future shareholders. The $12+ million purchase price for the technology came with an ongoing $1.1+ million non-cash charge to earnings per annum once revenue started to flow. The technology was originally amortized as an asset in accordance with GAAP accounting standards. But, by later taking an impairment charge in 2009, the asset was effectively written-down to zero, meaning that BioLargo still owns the technology it had booked it as an “intangible asset” that was written-off, eliminating any more ongoing amortization expenses. Those figures are factored into the overall deficit, even though they have no ongoing implications to the company’s operations. By taking the write-down, the ongoing expense is gone and will not affect future earnings per share calculations, whereas they once could have.

Another interesting component that is easily overlooked is the $1.93 million in aggregate principal amount outstanding on various promissory notes and $750,039 of outstanding accounts payable and accrued expenses that BioLargo had on its books as of the quarter ended September 30, 2011 (their quarterly latest filing). The operative words surrounding that debt are “We may pay the principal and interest due on these notes in cash or in stock, at our option, at maturity.” In fact, putting the filings under a microscope shows that all of the true debt of the company is mandatorily convertible to equity on a fixed schedule at fixed prices. Deciphering regulatory filings may sometimes seem like running an accounting obstacle course, but when all is said and done with the BLGO books, it is not unfair to say that the outstanding debt of BioLargo could easily be thought of as equity because of the mandatory conversions.

While there will be some nominal dilution over time as conversions happen, the company’s capital position will be preserved for continuing agreements that generate revenue. The company has been running at a low burn rate of about $1.5 million a year for the last 4 years while it was going through extensive test marketing, research and development to validate their proof of claims, intellectual property protection (27 new patents filed), new licensing agreements, manufacturing and overall growing pains. With that in mind, and potential revenue from its first licensing deal estimated at a low end of $3.5-$5.0 million annually, it would not be a stretch to expect cash from sales to cover BioLargo’s operating expenses.

As mentioned, the Central Garden deal is enough to pave the gravel road to profitability, but it is actually only a small tip of the iceberg and held in the forefront of discussion because it is expected to begin performing in the short-term. After all, it’s only one agreement. As the article began, “potential” is what separates the wheat from the chaff in the developmental company investing business and provides foresight for bigger things to come. For example:

The company has recently purchased a 50% interest in the patents and other intellectual property surrounding the Isan system, a proven iodine-based disinfection system in use across many industries currently. The purchase not only opens the door to more near-term revenues, but is a perfect fit for current BioLargo technologies to become a staple in agriculture production, processing and food safety programs.
BioLargo has been selected as a founding member of a Canadian NSERC (Natural Sciences and Engineering Research Council) “research chair” formed to solve the contaminated water and tailings ponds problems associated with the oil sands industry. Canada’s Alberta Oil Sands are the second largest deposit of oil in the world, but have faced great scrutiny due to water pollution. BioLargo’s technologies can provide a solution to a major issue in the world’s largest industry and they have been recognized by the NSERC for what they have to offer. Now that’s potential.
BioLargo’s technology also has obvious applications in the medical industry and the company is quietly assembling the tools to head into that field as evidenced by a recent hire of a Key Medical Industry Executive- Tim Johnson.
If leadership is a concern for investors, BioLargo has brought in leaders with unparalleled credentials to help gear up for the big league, such as former Halliburton Chief Technology Officer, Dr. Vikram Rao, as a senior advisor to capitalize on initiatives in the oil industry; former Pepsi-Cola International VP of Technical Services Harry DeLonge as a senior advisor to assist in penetration in the food and beverage industry; and added John S. Runyan, Former President and CEO of Associated Grocers and Senior Executive of Fleming Companies, to its Board of Directors that also just added Kent C Roberts, with more than 25 years of senior capital markets experience.

For the sake of any brevity that is left, investors are encouraged to visit the BioLargo website and read their corporate press releases to better understand where the company could be headed in the future.

BioLargo has a series of loyal investors that have supported the company through the most trying economic climate of our lifetime through capital raises tallying nearly $6 million since 2008. Apparently, those investors have read between the lines of the financial reports.

Ultimately, the books for a company with a long history such as that of BioLargo can really be viewed as a case of rather strict public company accounting compliance, that requires a diligent review, which frankly most investor’s just won’t do.

Separating the actual invested capital away from the history of the shell company and recognizing that any looming debt will be converted to clear the books, provides a clearer view and representation of the way that BioLargo is operating today as it nears stronger revenue streams. The fact is that the company has proven itself well-qualified to operate within its own means since the merger in 2007 and there’s not much reason to expect anything different as larger-scale sales begin to happen.

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Distributed by Viestly

Monday, November 28, 2011

Hepatitis C Virus (HCV) Biotech/Pharma Stocks: (OTC: AEMD), (Nasdaq:VRUS), (VRTX)

Hepatitis C Virus (HCV) Biotech/Pharma Stocks: (OTC: AEMD), (Nasdaq:VRUS), (VRTX)Palm Beach, FL 11/28/11 (StreetBeat) -- www.InvestorIdeas.com, a global investor research portal for independent investors, issues a biotech/pharma investor snapshot for stocks involved in the treatment of Hepatitis C Virus (HCV). Over 170 million people worldwide are chronically infected with Hepatitis C. The sector made headlines earlier this week as Pharmasset, Inc. (Nasdaq:VRUS ), traded up over 84% on acquisition news.

Gilead Sciences, Inc. (Nasdaq:GILD) and Pharmasset, Inc. (Nasdaq:VRUS) reported the companies have signed a definitive agreement under which Gilead will acquire Pharmasset for $137 per share in cash.

What does this mean for the sector? Are there other potential acquisitions? Some say this acquisition makes Vertex Pharmaceuticals Inc (VRTX ) look relatively cheap.

Pharmasset (Nasdaq:VRUS ) has three clinical-stage product candidates for the treatment of chronic hepatitis C virus (HCV) advancing in trials in various populations. The company’s lead product candidate, PSI-7977, an unpartnered uracil nucleotide analog, has recently been advanced into two Phase 3 studies in genotype 2 and 3 patients. Both studies will utilize 12 weeks of treatment with PSI-7977 in combination with ribavirin. One study will compare this all-oral regimen against 24 weeks of the standard-of-care pegylated interferon/ribavirin in treatment-naïve patients, and the second study will compare the all-oral regimen to placebo in interferon-intolerant/ineligible patients. A third Phase 3 study in genotype 1 patients will be initiated in the second half of 2012, the design of which is dependent on the outcome of Phase 2 studies which are evaluating PSI-7977 in various combinations in genotype 1-infected patients. If successful, this strategy could lead to an initial U.S. regulatory approval of PSI-7977 in 2014. PSI-938, an unpartnered guanosine nucleotide analog, is being tested in a Phase 2b interferon-free trial as monotherapy and in combination with PSI-7977 in subjects with HCV of all viral genotypes. Mericitabine (RG7128), a cytidine nucleoside analog, is partnered with Roche and is being evaluated in three Phase 2b trials. Roche is responsible for all aspects of the development of mericitabine.

Gilead’s research and development portfolio includes seven unique molecules in various stages of clinical development for the treatment of HCV.

James A. Joyce, Chairman and CEO of Aethlon Medical, Inc. (OTCBB: AEMD) recently updated shareholders on November 16th, “Our Hemopurifier® has demonstrated broad-spectrum capabilities against viral pathogens, including HCV, the human immunodeficiency virus (HIV), and a variety of tested bioterror and pandemic threats. Specific to treating HCV, we previously conducted studies that demonstrated the safe administration of our Hemopurifier® in HCV-infected dialysis patients whose average viral load reductions exceeded 50% during each four-hour treatment. These results were obtained in the absence of any drug therapy.”

Vertex Pharmaceuticals Inc (Nasdaq: VRTX) announced earlier in November its interim results from ZENITH, an ongoing Phase 2 study designed to assess the safety, tolerability and efficacy of multiple 12- and 24-week response-guided treatment regimens with VX-222 (100mg or 400mg), its lead polymerase inhibitor in development, in combination with INCIVEK™ (telaprevir ) tablets, pegylated-interferon and ribavirin in people with genotype 1 chronic hepatitis C who were new to treatment. On the basis of the results announced today and previously announced data from other treatment arms of the ZENITH study, Vertex intends to start a Phase 3 study to evaluate a total treatment duration of 12 weeks with this four-drug regimen in treatment naïve and relapser patients with genotype 1 chronic hepatitis C.

More about Aethlon Medical (OTCBB: AEMD)
The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a contract with the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.

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Friday, November 4, 2011

Inhibitex (Nasdaq: INHX) Shares Soar as Investors See Another Pharmasset in the Making

Inhibitex (Nasdaq: INHX) Shares Soar as Investors See Another Pharmasset in the MakingTallahassee, FL 11/4/11 (StreetBeat) -- Shares of Inhibitex (Nasdaq: INHX) more than doubled Friday morning after the company released promising new data on its hepatitis C drug candidate.

The Inhibitex drug INX-189 belongs to the same "nucleoside" class of potent oral hepatitis C drugs as Pharmasset's (Nasdaq: VRUS) heralded PSI-7977. The difference, of course, is that Inhibitex's market value is $300 million, or at least it was going into Friday's trading. Pharmasset's market value is close to $6 billion.

Investors are hoping that the magical Hep C pixie dust that has made Pharmasset the best-performing biotech stock this year will work its charms on Inhibitex as well.

Inhibitex shares soared 133% to $9.25 in pre-market trading after the company reported a 4.25 log drop in Hep C viral load after 7 days of treatment with a 200mg dose of INX-189 in treatment-naive patients. No serious adverse events were reported. That result is comparable to the viral load decline demonstrated by Pharmasset's PSI-7977 in an earlier study.

Nucleoside or "nucs" have become the belles of the Hep C drug ball because of their potential as a backbone of future all-oral combination Hep C therapy. Pharmasset's nuc PSI-7977 has garnered the most attention, but companies like Inhibitex and Idenix Pharmaceuticals (Nasdaq: IDIX) are also developing their own Hep C nucs.

Pharmasset shares were down 4% to $74.80 in early Friday trading, likely due to competitive concerns stemming from the INX-189 data. In Friday's release, Inhibitex said it was moving forward with new studies of INX-189 including one in combination with an another undisclosed direct-acting antiviral Hep C drug.

The new Inhibitex data on INX-189 comes on the eve of the American Association for the Study of Liver Disease (AASLD) annual meeting, which will feature important presentations of new hepatitis C drug research.

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Distributed by Viestly

Wednesday, September 21, 2011

Planned Clinical Trials at Dana-Farber/Harvard University Cancer Center a Big Deal for Little Cellceutix (OTCQB:CTIX)

Planned Clinical Trials at Dana-Farber/Harvard University Cancer Center a Big Deal for Little Cellceutix (OTCQB:CTIX)Cellceutix Corporation (OTCQB:CTIX) disclosed that it has signed a laboratory agreement with Dana-Farber Cancer Institute, Harvard University’s cancer hospital, for its planned Phase I clinical trial for Kevetrin™, Cellceutix’s novel cancer compound for the treatment of drug-resistant cancers. While entering clinical trials is a milestone event for any biotechnology firm, having the trial at the world’s number one cancer research center speaks volumes for the potential of Cellceutix and Kevetrin™. DF/HCC, is afforded the ability to be extremely selective as to which drugs in development it will devote its resources and they do not seem to pick a small drug maker very often.

Of course, there are a whole host of big pharma that have conducted, or are conducting, clinical trials at DF/HCC including the likes of Pfizer, Inc. (NYSE:PFE), Astrazeneca PLC (NYSE:AZN) and Eli Lilly & Co. (NYSE:LLY), but small caps are few and far between. Although they may exist, no Over the Counter or OTCQB-listed companies were found, further showcasing the extreme rarity of Dana-Farber/Harvard Cancer Center agreeing to host a clinical trial of a small, pre-clinical company.

While a trial at DF/HCC, by no means implies impending achievements or drug approval by the Food and Drug Administration, some major drugs have come through the cancer center and have led to great successes for companies. Millenium Pharmaceuticals researched bortezomib (Velcade®) at Dana-Farber as an indication for multiple myeloma. Velcade® received FDA clearance in only seven years after initial synthesis even with early-stage trials moving notably slow as the drug moved through three different companies at first. Millenium was bought by Takeda Pharmaceutical Company (TSE:4502) in April 2008 for nearly $9 billion with Velcade® as its flagship product which is still undergoing research at Dana-Farber for different indications.

It is an arduous endeavor to seek approval for clinical trials at the world’s elite cancer center as each and every component of the initial review process can be painstakingly slow as a result of required procedural assessments. One can only imagine the number of committees that review the application. Unlike other hospitals which may provide a more expeditious service, the recognition and expertise that accompanies an outfit like Dana-Farber/Harvard Cancer Center showing a desire to research a particular drug is well worth the patience.

Having clinical trials hosted at DF/HCC should place Cellceutix at the forefront of developmental biotechs of all sizes, regardless of exchange listing; especially those in Phase I and a good portion of those in Phase II at lesser-known cancer centers. While no hospital ensures a positive outcome to clinicals, it could be discerned that odds are increased due to the selective nature of compounds that are permitted to enter trials at DF/HCC. Moreover, due to Kevetrin™ targeting drug-resistant cancers, Cellceutix will be researching their drug on terminal cancer patients (their ideal candidate) which raises the bar during Phase I as not only will the primary endpoint of safety be evaluated, but the possibility of efficacy being shown is a reality of the trials. Any sign of efficacy for a completely novel compound significantly increases the odds of expeditious development designations from the FDA.

Novel drugs are a hot commodity for any indication at the moment. Pharmasset, Inc. (NASDAQ:VRUS) is developing PSI-7977 as a treatment for Hepatitis C and posting strong results. The data has helped drive shares of VRUS northward by more than 250 percent so far this year to the $80 range (which would actually be $160 per share except for a 2 for 1 forward split in August). Split-adjusted shares were as low as $3.81 for VRUS just 2-1/2 years ago. Only in Phase II with its drug, Pharmasset boasts a nearly $6 billion market cap and serves as a solid reminder to followers of Cellceutix (with its current $32 million market cap and $0.37 per share price tag) as to what can happen in the mid-term with a potent drug candidate.

Cellceutix and Kevetrin™ have apparently impressed Dana-Farber/Harvard Cancer Center and its associates. Moreover, Cellceutix has Dr. Krishna Menon at the research helm as Chief Scientific Officer. Dr. Menon knows a bit about developing successful drugs from his time as a lead researcher at Eli Lilly where he won a President’s Award for his work in the development of multi-billion dollar cancer drugs Gemzar and Alimta. In June of this year, commenting on the robust pre-clinical research the has been generated studying Kevetrin™ on many different strains of cancer including breast, colon, lung, pancreatic and leukemia, Dr. Menon stated in a Cellceutix press release, “In all my years as a researcher, I have never seen anything like Kevetrin™.” That’s a strong statement and certainly food for thought about where Cellceutix could be in the near future.

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