Stem Cells Versus Aging, Fountain of Youth (BTIM, GERN, ACTC)

March 16, 2010 · Filed Under Financial, stem cells · 1 Comment 

How many movies and legends are based upon eternal youth?  Hundreds or thousands for sure.  BioTime, Inc. (NYSE Amex: BTIM) is seeing a massive surge of interest today after the company announced a “Peer-Reviewed Scientific Publication on the Reversal of the Developmental Aging of Normal Human Cells.”

The company is a small-cap biotechnology company (approximately $250 million) pursuing the development and marketing of products in the field of stem cells and regenerative medicine.   The article was released online today in the peer-reviewed journal Regenerative Medicine ahead of the print publication showing that the aging of human cells can be reversed.  The company noted that this “may have significant implications for the development of new classes of cell-based therapies targeting age-related degenerative disease.”

BioTime and its collaborators demonstrate the successful reversal of the developmental aging of normal human cells according to the article.  The full article at Future Medicine is here.

BioTime is is led by Dr. Michael West as CEO.  He was the Founder of Geron Corporation (NASDAQ: GERN), where he served until 1998.  From 1998 to 2007 he was President and Chief Scientific Officer of Advanced Cell Technology Inc. (OTC: ACTC).  Dr. West also gave a CNBC video here just this morning.

Also noted was that the aged differentiated cells became young stem cells capable of regeneration and transforming adult human cells back to a state very similar to embryonic stem cells.  Does it come without exception or without differences?  No.

Still, this is sending BioTime shares through the roof.  Usually we see just over 100,000 shares trade hands.  Today we have 3.3 million shares traded at 12:50 PM EST and BioTime’s stock is up 28% at $7.43 today.

JON C. OGG

Diabetes & Insulin War About To Heat Up (MNKD, LLY, NVO, PFE, BMY, AZN, GERN)

January 6, 2010 · Filed Under Diabetes, fda, Financial, stem cells · 2 Comments 

MannKind Corp. (NASDAQ: MNKD) has not gone without its critics over the company’s inhaled insulin.  The company has an upcoming review that will be a make or break event for the company.  The company is about to face a potential do or die test next week as the FDA is set to decide the fate of the company’s inhaled insulin.  MannKind’s Afresa is designed to deliver a fast acting insulin that is supposed to be more effective than the injected products.  This would put the company in competition for insulin with Eli Lilly & Co (NYSE: LLY) and Novo Nordisk (NYSE: NVO) for their insulin delivery.

One of the biggest hurdles MannKind faces is that inhaled insulin products have been tried and tested by others, and they have failed or have fallen far short of the expectations set ahead of time.  Pfizer Inc. (NYSE: PFE) discontinued its Exubera as an inhalable insulin.

The FDA is set to make a ruling on Afresa’s approval by January 16, which means that the JAN-2010 CALL options may or may not expire before such ruling is made.  The FDA can always delay, and some reports hint at a later date now.
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Top 2010 Established Biotech Stock Picks for Upside (MNKD, THRX, DNDN, INCY, ILMN, ALNY, GILD, SVNT, AMGN, ONXX, PDLI, OSIP, CELG)

BioHealthInvestor.com wanted to put together a list of key biotech and BioHealth-related stocks that had the most upside for 2010 according to consensus analyst price targets.  This is of course no exact science for many reasons, but getting a lot of consensus price targets together is often a sign of at least where to start when looking for upward price targets in stocks.  And we all know that BioHealth and biotech stocks often offer the upside of the century as these companies all hold a bit of your own personal lottery ticket in all of their share prices.

After taking a look at our normal universe of biotech and biohealth related stocks. it was obvious that MannKind Corp. (NASDAQ: MNKD) still has the most upside from the consensus price targets IF it is hit.  Then in order of expected share price appreciation comes Theravance Inc. (NASDAQ: THRX), Dendreon Corp. (NASDAQ: DNDN), Incyte Corporation (NASDAQ: INCY), and then came Illumina Inc. (NASDAQ: ILMN), Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY), and Gilead Sciences Inc. (NASDAQ: GILD).

The stocks above all had upside of over 25%.  The other stocks here are the ‘lower rung’ of upside expectations but are all still offering over 20% upside to the consensus analyst price targets (again IF they are hit).  Of the 13 stocks with markets caps of $750 million (or almost $750 million) which we cover, these still had upside of over 20% except a few: Savient Pharmaceuticals, Inc. (NASDAQ: SVNT), Amgen Inc. (NASDAQ: AMGN), Onyx Pharmaceuticals Inc. (NASDAQ: ONXX), PDL BioPharma, Inc. (NASDAQ: PDLI), OSI Pharmaceuticals Inc. (NASDAQ: OSIP), and Celgene Corporation (NASDAQ: CELG).
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Quest For 10-Baggers in BioHealth in 2010 (JAZZ, TRGT, VNDA, DNDN, HGSI, CGEN, BNVI, QCOR, ACHN, PSDV, ATHX, SNSS, AVNR, BIOD, ALXA, CTIC)

If one thing was noticed in biotech stocks, or BioHealth stocks as we often say, it was that investors, traders, and speculators all piled into the chase for the next ten-bagger late in the year.  When you have as many biotech and BioHealth stocks that ran over 1,000% in 2009 that is only to be expected…. hence the 10-bagger comments.  We had many biotech and biohealth shares rally from their lows significantly this year, with companies such as Jazz Pharmaceuticals, Inc. (NASDAQ: JAZZ), Targacept, Inc. (NASDAQ: TRGT), Vanda Pharmaceuticals, Inc. (NASDAQ: VNDA), Dendreon Corp. (NASDAQ: DNDN), and Human Genome Sciences, Inc. (NASDAQ: HGSI) all being in or having been in the 10-bagger club this year.

But late in 2009 we started seeing an onslaught of low-priced stocks with small cap or micro-cap values running rapidly higher on news.  In some cases these faded, and in some not.  We saw the traders run up shares of Compugen Ltd. (NASDAQ: CGEN), Bionovo, Inc. (NASDAQ: BNVI), Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR), Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN), pSivida Corp. (NASDAQ: PSDV), Athersys, Inc. (NASDAQ: ATHX), Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS), and AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) on news late in 2009.  Also covered as potentials for this are Biodel Inc. (NASDAQ: BIOD), Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA), and Cell Therapeutics, Inc. (NASDAQ: CTIC).

We have reviewed each of these and given a synopsis for each to see if these could be the 10-baggers for 2010.
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BioHealth IPO Focus: Tengion, Organ Replacements (TNGN)

December 24, 2009 · Filed Under Cancer, Financial, genomics, stem cells · 2 Comments 

If you have heard horror stories about real human kidney theft, that may be a thing of the past.  If this actually works.  An IPO filing this week revealed a rather interesting company that we will look forward to how it prices in 2010.  Tengion, Inc. filed for an initial public offering of its common stock.  While no terms were indicated for its IPO, the filing notes a sale of up to $40.25 million in common stock and Piper Jaffray was designated as he underwriter.  This is not quite stem cells, not RNAi, and not quite genomics.  The company is focusing on a range of replacement organs and tissues.

Here is how Tengion desrcibes itself:

We believe we are the only regenerative medicine company focused on discovering, developing, manufacturing and commercializing a range of replacement organs and tissues, or neo-organs and neo-tissues. We currently create these functional neo-organs and neo-tissues using a patient’s own cells, or autologous cells, in conjunction with our Organ Regeneration Platform. We believe our proprietary product candidates harness the intrinsic regenerative pathways of the body to regenerate organs and tissues that are native-like, or substantially similar to native organs and tissues. We manufacture our product candidates in our scalable facilities using efficient and repeatable proprietary processes and we have implanted our neo-organs in clinical trials. We intend to develop our technology to address unmet medical needs in urologic, renal, gastrointestinal and vascular diseases.

Our lead product candidate, the Neo-Urinary Conduit, is an autologous implant that catalyzes regeneration of native-like bladder tissue for bladder cancer patients requiring a urinary diversion following bladder removal, or cystectomy. This tubular conduit passively transports urine from the ureters, through a hole in the abdomen, or stoma, into a removable, disposable bag, or ostomy bag. We have an effective investigational new drug application, or IND, and expect to start a Phase I clinical trial for this product candidate in the first half of 2010 in bladder cancer patients. We have also applied our technology in two Phase II clinical trials for our Neo-Bladder Augment for the treatment of neurogenic bladder, or dysfunctional bladder due to some form of neurological disease or condition. Our Neo-Urinary Conduit leverages recent advances in our technology platform that enable us to produce this product candidate more quickly and efficiently, and less expensively, than our Neo-Bladder Augment, enabling us to address larger market opportunities. Our product pipeline includes several candidates in early stage development, such as our Neo-Kidney Augment for patients with advanced chronic kidney disease, or CKD.

It also lists the following steps for the platform:

  • Isolation and expansion. We receive a small tissue sample, generally by routine biopsy, and isolate the necessary committed progenitor cells, which are relevant to a specific organ or tissue type. Committed progenitor cells have not yet developed into a single cell type and retain the ability to promote regeneration. We then use our proprietary cell growth process to grow, or expand, the progenitor cells.
  • Seeding and growth. We place, or seed, these expanded cell populations on a bioabsorbable scaffold and put the seeded structure in a bioreactor, or a closed container used for enhancing biological growth under controlled conditions.
  • Implantation. The neo-organ or neo-tissue is shipped by a standard overnight courier service and implanted by a surgeon using standard surgical procedures.
  • Regeneration. Based on clinical and preclinical data, we believe that our implanted product candidates serve as templates for the body to regenerate native-like organs and tissues. Blood vessels and nerves grow into the implanted neo-organ or neo-tissue and the scaffold is gradually absorbed by the body. In preclinical tests, we have observed that the newly grown tissue integrates with its surroundings and becomes substantially indistinguishable over time from the native organ. Clinical results indicate that the body regulates the growth and development of the organ to ensure that it is not under- or over-developed.

The company’s Organ Regeneration Platform is based on work that began in the early 1990s at Children’s Hospital Boston and Massachusetts Institute of Technology, and continued at the Wake Forest Institute for Regenerative Medicine and at the company.  5% stockholders are listed as follows:

  • Oak Investment Partners XI, Limited Partnership 18,034,824 shares for a 19.6% stake.
  • HealthCap Venture Capital 13,153,457 million shares for a 14.3% stake.
  • Johnson & Johnson Development Corporation 11,522,503 shares for a 12.5% stake.
  • Brookside Capital Partners Fund, L.P. 7,930,273 shares for a 8.6% stake.
  • Bain Capital Venture Entities 7,850,970 shares for a 8.5% stake.
  • Quaker BioVentures 7,671,363 shares for a 8.3% stake.
  • L Capital Partners SBIC, L.P. 5,900,528 shares for a 6.4% stake.

The full SEC Filing is here.  Tengion plans to list on the NASDAQ under the stock ticker “TNGN.”

JON C. OGG

Athersys, The Next Wannabe 10-Bagger in Biotech (ATHX, PFE)

December 21, 2009 · Filed Under Financial, stem cells · Comments Off 

Athersys, Inc. (NASDAQ: ATHX) is soaring on the announcement by the company that it entered into a development and commercialization pact with Pfizer Inc. (NYSE: PFE).  The pact is for MultiStem(R) for the treatment of Inflammatory Bowel Disease.  As traders and investors look (and hope) for potential 10-baggers in small-cap and low-priced biotech shares, this one is seeing very exacerbated trading activity.

Athersys will receive a $6 million cash payment up front from Pfizer to fund the research during the first and initial part of this pact.  The standout note from Pfizer is that it noted how Athersys represents a cornerstone of Pfizer’s stem cell and regenerative medicine plans.  Athersys is eligible to receive milestone payments of UP TO $105 million upon the successful achievement of certain milestones in development, regulatory approvals and commercial limits.

Athersys shares are up a whopping 192% at $2.92 today after closing at 1.00 on Friday.  Trading volume is almost 6.8 million shares as of 12:15 PM EST, and the average trading volume is only 30,000 shares per day… Sorry, it was only that amount.  Even after the huge gain, the market cap is listed as a mere $54 million.

To show how much traders are willing to chase the companies on any such news, this stock has an intra-day high listed as $3.95.  Athersys was very briefly an $8.00 stock back in 2007 when it came public.  In 2008 it slid from over $4 down to under $1.00 throughout the year.  Shares had recovered off of lows, but nothing at all like what we are seeing today.

As of September 30, 2009, the company had $18.8 million in cash and short-term investments, and listed another $3.94 million in long-term investments.  Its total liabilities are listed as only $1.665 million.

JON C. OGG
DECEMBER 21, 2009

NIH Brings Back Stem Cell Interest (STEM, GERN, ASTM, NBS, KOOL, OSIR, CYTX)

December 2, 2009 · Filed Under Financial, R&D, stem cells · Comments Off 

The National Institutes of Health has just today announced the approval of the first 13 human embryonic stem cell lines for use in NIH-funded research under the NIH Guidelines for Human Stem Cell Research adopted in July 2009.  Children’s Hospital Boston developed 11 of the approved lines and Rockefeller University in New York City developed two of the approved lines.  While those are private and non-public, this has some excitement around the other embryonic stem cell line companies because the NIH said that an additional 96 lines have been submitted to NIH for either internal administrative review or consideration, including more than 20 that will be considered on December 4, 2009.  We are seeing strength as follows:

  • StemCells Inc. (NASDAQ: STEM) up 5.5% at $1.14; 52-week range $0.89 to $3.07; market cap $135 million
  • Geron Corporation (NASDAQ: GERN) up 4.8% at $5.70; 52-week range $3.00 to $9.24; market cap $522 million
  • Aastrom Biosciences, Inc. (NASDAQ: ASTM) up 5.5% at $0.288; 52-week range $0.24 to $0.78; market cap $50 million

Neostem, Inc. (AMEX: NBS) is actually in adult stem cells, and shares are down 2.3% at $1.68; 52-week trading range is $0.41 to $2.72; market cap $61.3 million.  ThermoGenesis Corp. (NASDAQ: KOOL) is also tied to adult stem cell lines but in products targeting stem cell companies; shares are up 3.4% at $0.61, its market cap is $34 million, and the 52-week range is $0.31 to $0.89.

Elsewhere in companies tied to stem cells…  Osiris Therapeutics, Inc. (NASDAQ: OSIR) is up 0.4% at $6.89; 52-week range $5.35 to $21.65; market cap $225 million.  Cytori Therapeutics, Inc. (NASDAQ: CYTX) is down 2.2% at $5.75, its market cap is $222 million, and the 52-week range is $1.42 to $6.04.

For a full data and explanation from the NIH website on what was approved, that can be found here.

JON C. OGG
DECEMBER 2, 2009

Stem Cell Study Starts in PMD (STEM)

November 23, 2009 · Filed Under genomics, stem cells · Comments Off 

StemCells Inc (NASD: STEM) has announced this morning that it and collaborator UCSF have initiated the enrollment of patients in the first ever clinical study of neural stem cells as a potential treatment in Pelizaeus-Merzbacher Disease (PMD), a neurological disorder that primarily afflicts children.

The company noted that the nature of this study is important on its own, but equally important is the fact that the findings from this trial may help also lead to potential stem cell treatments of other myelination disorders including multiple sclerosis and cerebral palsy.

The two have begun patient recruitment for a Phase I clinical trial designed to test the safety and preliminary efficacy of its HuCNS-SC® purified human neural stem cells.  Also noted was that the study is being conducted at the University of California, San Francisco Children’s Hospital.

PMD results from a defective gene and is characterized by a lack of myelin, a substance that surrounds and insulates nerve cells’ communications fibers, which then makes the body unable to properly transmit nerve impulses.  This leads to the loss of neurological function and eventually death in the most severe forms of PMD, and there are currently no effective treatment options for patients with PMD.

So far there is still a lukewarm reception.  Shares are up 1%, but this is only a $1.00 stock.  Starting trials is still a far cry from having positive trial results.

JON C. OGG
NOVEMBER 23, 2009

Geron Suppliers Register Shares for Sale (GERN)

November 17, 2009 · Filed Under Financial, stem cells · Comments Off 

Geron Corp. (NASDAQ: GERN) on Monday filed a registration statement for the resale of shares by existing holders.  This is not a huge deal on the surface as it is ‘only’ 344,120 shares of common stock with a listed value of roughly $2 million.  The following share counts are being filed to possibly be sold as follows:

  • 55,545 shares by Hongene Biotechnology Limited,
  • 93,244 shares by Samchully Pharm. Co., Ltd.
  • 195,331 shares of our common stock by ReSearch Pharmaceutical Services, Inc.

Geron has already noted that it will not receive any of the proceeds from the sale of these shares.  As you will also see, this represents an insignificant number of shares in the grand scheme of things.

As of November 11, 2009, Geron had 200,000,000 shares of common stock authorized for issuance and 91,971,441 shares of common stock outstanding. also as of November 11, 2009, Geron has reserved for future issuance approximately 25,831,114 shares of common stock for the company stock plans, potential milestone payments and outstanding warrants.

On November 10, 2009, in payment to Hongene Biotechnology Limited under a manufacturing agreement where Hongene is making certain raw materials intended to be used for the manufacture of drug product for use in human clinical trials, Geron issued to Hongene 55,545 shares of common stock.

On November 10, 2009, in payment to Samchully Pharm. Co., Ltd. under a manufacturing agreement where Samchully is performing certain services and manufacturing certain raw materials and products for use in human clinical trials, Geron issued to Samchully 93,244 shares of common stock.

On November 10, 2009, in payment to ReSearch Pharmaceutical Services, Inc. under a project agreement where RPS is providing certain services in support of Geron’s clinical programs, the company issued 195,331 shares to RPS.

Some insider sales by existing holders have ominous implications, but that does not appear to be the case here on the surface.

Jon C. Ogg

Opexa Therapeutics (OPAX) Up 25% On Milestone

September 23, 2009 · Filed Under stem cells · Comments Off 

Opexa Therapeutics (OPAX) is up 25% to $4.31, still below its 52-week high is $6.93

The firm said it has achieved its first technology transfer milestone in connection with the company’s recently announced exclusive stem cell agreement with Novartis, one of the world’s largest healthcare companies. The milestone was completed on schedule and triggers a payment of $500,000 to Opexa

Opexa recently announced that it entered into an exclusive agreement with Novartis for the further development of Opexa’s novel stem cell technology. Under the terms of the agreement, Opexa received an upfront cash payment of $3 million and was entitled to an additional $1 million as a technology transfer fee to be paid over the course of a six month period. The $500,000 milestone is part of this $1 million technology transfer fee. Total payments to Opexa, including the upfront payment, the technology transfer fee and development and commercial milestone payments could exceed $50 million not including royalties. Opexa is also eligible to receive royalty payments from the sale of any products resulting from the use of the technology and retains an option on certain manufacturing rights

Douglas A. McIntyre

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