ImmunoCellular (OTCBB: IMUC) Shareholder Update Validates Strong Potential for Growth

Tallahassee, FL 2/10/12 (StreetBeat) – Biotechnology topics are hot in the investment community. Acquisitions are regularly being reported, new treatments are advancing in cancer therapy and stem cell research is being pursued down multiple avenues for its core competencies of repairing damaged body parts at the root of the problem. Bringing together these topics points to the direction of ImmunoCellular Therapeutics, Inc. (OTCBB:IMUC), a clinical stage biotechnology company targeting cancer stem cells by using the power of immunology and working in the same industry as Biogen Idec Inc. (NASDAQ:BIIB) and Amgen, Inc. (NASDAQ:AMGN). ImmunoCellular Therapeutics presents an investment opportunity that outstrips its much larger competitors as discernible from a recent letter to shareholders from IMUC President and CEO Manish Singh, Ph.D.

The company had a banner year in 2011 with a major milestone being hit with the initiation of a Phase II study for its flagship product candidate, ICT-107 (a dendritic cell-based vaccine). This Phase II study builds upon strong data collected in Phase I as an indication for glioblastoma, the most aggressive form of brain cancer. Phase I research showed ICT-107 outperforming current treatments by showing an 80% survival rate after two years compared to today’s rate of a mere 26.5% and a three-year survival rate of 55% as compared to 15% with standard care treatments. An amazing 38% of the patients treated with ICT-107 continue to show no signs of tumor recurrence after three years as opposed to the bleak rate of 6% in patients receiving standard care. No serious adverse events from the ICT-107 have been observed.

Moreover, ImmunoCellular has completed a $10.4 million financing, paving the way financially for the company through at least the end of 2013 for the ICT-107 Phase II trial and potentially the start of clinical trials for two more vaccines utilizing the same scientific principles as ICT-107 (ICT-140 for ovarian cancer and ICT-121 for recurrent glioblastoma). The financing leaves IMUC in an envious position with cash on hand in excess of $16 million, a strong balance sheet thanks to a lean infrastructure, a robust group of life science investors and absolutely no need for dilutive practices.

The Phase II study is more than halfway through enrollment with more than 115 patients enrolled out of the estimated 160-200 through initiation of the trial at 23 centers, including some of the most prestigious brain tumor treatment centers in the U.S. Enrollment is expected to be completed by the second quarter 2012.

The letter to shareholders covered the whole gamut of ImmunoCellular’s operations highlighting that the company is not only well-positioned for today, but is also forward-thinking and taking the necessary steps to secure its position as a leader in the immunotherapy sector. Amongst its many developments in the last year, IMUC has manufacturing agreements in place for ICT-107 formulations with Progenitor Cell Therapy, a subsidiary of NeoStem (AMEX:NBS); initiated a strategic collaboration and new Joint Venture (called Caerus Discovery) with BioWa to develop enhanced versions of IMUC antibodies; and expanded its patent portfolio.

Industry experts are recognizing the ingenuity of ICT-107 and giving it extensive praise, including it being hailed as one of the “100 Great Investigational Drugs” by R&D Directions, a “Top 10 Licensable Oncology Products” by Windhover, listed as a top ten therapeutic cancer vaccines by Fierce Biotech and being featured on CBS News as a “promising vaccine” for brain cancer.

ImmunoCellular has clearly established itself as a pioneer in immunotherapy and possesses the technology that could truly change the landscape of oncology. They are well-funded and organized, have an outstanding management team; they’re producing stellar clinical data and carry a price point that offers an upside which is arguably larger than any of its peers. All of these qualities align IMUC as a prime acquisition target in a field of merger-hunger major pharmas looking to take the lead in any given field. Keep an eye on this emerging micro-cap firm that could be shepherding in the next generation of brain cancer therapy right before our eyes. Interested parties are encouraged to read the letter to shareholders from Dr. Singh, and keep an alert out for the company’s next SEC filing.

ImmunoCellular to Present at the 14th Annual BIO CEO & Investor Conference

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Amgen to Buy Micromet (Nasdaq: MITI) for $1.16 Billion

Orlando, FL. 1/25/12 (StreetBeat) -- Amgen (Nasdaq: AMGN) has agreed to buy Micromet (Nasdaq: MITI), a biotechnology company that develops cancer drugs, for $1.16 billion.

The offer of $11 a share represents a premium of 33 percent from Micromet’s closing stock price on Wednesday.

Micromet, which currently has no drugs on the market, designs cancer therapies that target blood and solid tumor cancers, including leukemia and non-Hodgkin’s lymphomas. The company has research facilities in Munich and is based in Rockville, Md.

Among Micromet’s drugs in development is blinatumomab, which treats acute lymphoblastic leukemia, that is now in Phase 2 trials.

“The acquisition of Micromet is an opportunity to acquire an innovative oncology asset with global rights and a validated technology platform with broad potential clinical applications,” Kevin Sharer, Amgen’s chief executive, said in a statement on Thursday. “Blinatumomab will serve as an important complement to our oncology pipeline.”

Amgen, which is set to reporting earnings after Thursday’s close, plans to acquire Micromet’s shares in two phases. A subsidiary of Amgen will buy at least a majority of Microment’s outstanding shares at $11 a piece. The parent company will then buy any remaining shares, at the same price. The deal will likely close in the first quarter, the company said in a statement.

Amgen is one of the world’s largest drug makers, with more than $15 billion in annual sales, however, the company has struggled to fill its pipeline with new blockbuster drugs. In the last five years, it has only introduced one runaway hit, denosumab, an osteoporosis treatment. Last year, the company slashed 6 percent of its research and development staff and issued a $5 billion share buy back in December. That month, the company’s current chief executive, Mr. Sharer, also announced his retirement. Robert Bradway, the chief operating officer and president, will replace him in May.

This would be the biggest acquisition by Amgen since it had agreed to acquire Abgenix for $2.2 billion in cash in 2005, according to Capital IQ data.

The pharmaceutical industry has been a bright spot for deal-making so far this year. Earlier this week, drug maker Roche Holding, announced a hostile $5.7 billion bid for Illumia, a genetic analysis service, in a bid to strengthen its diagnostic business. Separately, on Thursday, Celgene said agreed to buy Avila Therapeutics, a private biotechnology company, for $350 million in upfront cash and up to $195 million if certain targets are met.

Amgen was advised by Moelis & Company and the law firm of Sullivan & Cromwell. Goldman Sachs and the law firm of Cooley advised Micromet.

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Affymax's Shares Soar on Hope for Anemia Drug Approval

Orlando, FL 12/8/11 (StreetBeat) -- Affymax’s (Nasdaq: AFFY) stock is surging after government advisers recommended the company’s treatment for kidney failure patients be approved.

A panel of Food and Drug Administration expert advisers voted 15-1 to approve peginesatide, a treatment for dialysis patients with anemia caused by chronic kidney failure. The FDA, scheduled to make a final decision by March 27, is not bound by the recommendation.

It would be the first drug approved for Affymax, which lost more than $400 million over the past decade. Along with development partner Takeda Pharmaceutical of Japan, Affymax would take on Amgen (Nasdaq: AMGN) and its leading anemia drug Epogen. Takeda has sales rights for peginesatide outside of the US.

Shares of Affymax rose 35% to $7.96 in early trading Thursday. The stock rose earlier in the week on hope for a positive panel vote. Amgen rose 1% to $58.92.

Safety concerns with peginesatide have hurt Affymax’s stock, which traded above $24 a share in the first half of 2010. Affymax’s shares crashed in June of last year when research showed heart risks associated with taking the drug. However, that study involved patients who were not on dialysis. Affymax is seeking approval for treating those on dialysis. In briefing documents released earlier this week before Wednesday’s meeting of FDA advisers, the agency’s staff reiterated concerns about patient safety but noted the treatment worked.

If approved, Affymax will face a very dominant player in Amgen, which just last month signed supply agreements with the two largest kidney dialysis clinic operators in the US, according to Reuters. Amgen signed a 7-year contract with dialysis company DaVita to provide at least 90% of the clinic owner’s medicine needs. Amgen also has a multi-year deal with Fresenius Medical Care, though that deal is not exclusive, according to Reuters.

Robert W. Baird analyst Christopher Raymond estimates Amgen locked up 70% of the market for providing dialysis centers with drugs. He says, however, that the 30% remaining market share still represents a large sales opportunity, and he suspects some clinic operators may opt out of agreements if Affymax prices its drug lower than Epogen. Raymond recommends buying the stock and has a $13 price target on the shares.

On a conference call with investors and analysts Thursday morning, Affymax execs said they haven’t finalized a price. “We know the market is very price sensitive,” CEO John Orwin says.

As for the uphill battle against Amgen, Orwin says he believes customers -- the dialysis centers -- would welcome a competitor to Epogen. “We feel comfortable that there’s a pent-up demand out there,” he says.

Affymax’s drug also is designed to be dosed once a month, which is less frequent than Epogen. That allows Affymax to tout the convenience factor of the drug.

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