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In part I of this series, Neostem (NASDAQ:NBS) and Aastrom (NASDAQ:ASTM) stood out in a field of 6 stem cell biotechs with their advancing trials, recent financing, manufacturing capabilities and/or current revenue generation (not profitability as this will likely come with time, but rather just generation of funds now to reduce need for future financing). Here in part II we review 8 additional stem cell biotechs and their updates presented in February and March on their respective 2011 financials and accomplishments.

Leaders in this group are Pluristem (NASDAQ:PTSI), Advanced Cell Technology (OTCQB:ACTC) and Cytori Therapeutics (NASDAQ:CYTX). Pluristem's pipeline is advancing with a Phase II/III for critical limb ischemia (CLI) being planned and a manufacturing facility currently being completed. Although they have a long way to go to catch up with the revenue generating (and therefore networking capability) divisions of NeoStem, they are advancing with strong science and $43 million in cash at the end of 2011. Advanced Cell Technology's single-blastomere technology of extracting stem cells from embryonic stem cells without the destruction of the embryos has huge implications if it can be fully proven with no effects on developing fetuses (so far so good per published reports). The company recently announced intentions of uplisting to the NASDAQ stock exchange, but this does require a reverse split in order to be eligible for the uplisting. Shareholders were to vote on a 1:20 to 1:80 reverse split on April 26, so new potential investors should consider this when making their investment decisions. Cytori Therapeutics has applied for the CE Mark for its Celution System in no-option chronic myocardial ischemia. The company is expecting to hear a decision from the regulatory body in 1H 2012. They appear to be very conservative with their cash and hope to further reduce spending in 2012 after a headcount reduction in sales and marketing in late 2011.

Osiris Therapeutics (NASDAQ:OSIR) with an MCAP of $156.9 million reported its 2011 update on March 9th. Osiris reported $42.4 million for 2011 with $40.0 million from a Genzyme (GENZ) collaboration agreement, $1.0 million from the research, development and commercialization agreement with the JDRF and $1.3 million of revenues from their Biosurgery products. Results were comparable to 2010 in which they saw $43.2 million in revenue, including another $40.0 million from a Genzyme collaboration agreement. R&D expenses for 2011 were $19.2 million compared to $23.5 million in 2010. General and accounting expenses in 2011 were $7.9 million, which included $2.4 million of non-cash share based payments. G&A expenses in 2010 were $6.5 million, including $0.7 million of share-based payments.

The following pertinent 2011 stem cell research highlights were noted:

  • Expanded the company's commercial infrastructure for our lead products Grafix® and Ovation®, increasing Biosurgery revenue in the fourth quarter more than 130% over the previous quarter.
  • Achieved top scoring abstract at the 24th Annual Symposium on Advanced Wound Care for one of three abstracts the company presented describing the science and initial clinical results of Grafix, a living skin substitute.
  • Fully filed response to inquiries from the Biologics and Genetic Therapies Directorate of Health Canada regarding the Prochymal New Drug Submission (NDS) and post marketing commitments.
  • Completed enrollment in a 220-patient Phase II trial of Prochymal for patients experiencing their first heart attack.
  • Reported update on first-of-a-kind Phase II trial evaluating Prochymal for newly diagnosed type 1 diabetes, conducted in partnership with JDRF.

Pluristem Therapeutics, with an MCAP of $103.3 million, reported its 2011 update on February 29th. Pluristem's fiscal year actually ends on June 30th, but the CEO did note that the company had $43 million in cash and cash deposits on its 10Q. They also noted recently receiving its sixth consecutive payment from the Israeli government in the form of a grant "in support of our innovative technology" this time for $2.4 million.

The following pertinent 2011 stem cell research highlights were noted:

  • Pluristem plans to initiate a Phase II dose escalation trial using our PLX cells in muscle injury. Our cells will be administered into muscle routinely traumatized during hip replacement surgery in an effort to improve and shorten the rehabilitation time for the patient.
  • Pluristem is planning a Phase II/III pivotal trial at multiple sites in the USA and Europe for CLI (critical limb ischemia), the most severe form of PAD that afflicts approximately 3 million patients worldwide. The endpoint for this pivotal trial will be amputation free survival (AFS).
  • Pluristem recently announced the expansion of our activity in using PLX cells for the treatment of radiation exposure following discussions with several governmental authorities seeking effective radiation countermeasures that are readily available and easily administered.
  • We are on schedule with the build-out of our new manufacturing facility; which we believe will be one of the largest state-of-the-art, commercial-grade-capacity, good manufacturing practice (GMP) cell facilities in the world. We expect that our three dimensional (3D) expansion technology for manufacturing mass quantities of cells will give Pluristem competitive advantages for future product commercialization and potential collaborations. These advantages include being able to efficiently produce PLX cells in a controlled manner and the ability to manufacture specific PLX cell products for each indication we pursue.

Advanced Cell Technology, (OTCQB:ACTC) with an MCAP of $163.2 million, announced its 2011 review on March 1st. In the update, they noted expenditures of $13.6 million for 2011 versus $8.8 million for 2010. The company ended 2011 with $13.1 million in cash and equivalents relative to $15.9 million for 2010.

The following pertinent 2011 stem cell research highlights were noted:

  • Secured patent covering the single-blastomere technology allowing cultivation of human embryonic stem cells without embryo destruction
  • The Company also announced today that it expects to shortly file a preliminary proxy statement with the Securities and Exchange Commission in which it will seek shareholder approval for a reverse split of between 1-for 20 and 1-for 80 shares. The Company is pursuing the reverse split for the sole purpose of meeting the requirements necessary for a listing on the Nasdaq Global Market.
  • FDA and MHRA clearance for clinical trials using human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) to treat dry age-related macular degeneration (AMD) and Stargardt's Macular Dystrophy (SMD) in the US and Europe.
  • Commencement and dosing of patients in the first ever clinical trials using (hESC)-derived RPE cells to treat dry AMD and SMD.

ThermoGenesis Corp. (NASDAQ:KOOL), with an MCAP of $14.6 million, announced its 2Q 2012 fiscal update on February 9th (Fiscal year started July 1, 2012). For H1 2012, ThermoGenesis reported revenues of $9.6 million compared to revenues of $12.9 million in H1 in fiscal 2011. The company reported a net loss of $2.5 million ($0.15 per share) compared to a net loss of $554,000 ($0.04 per share) in the same period a year ago. The company ended H1 with $8.7 million in cash compared with $12.3 million at the end of fiscal 2011.

The following pertinent 2011 stem cell research highlights were noted:

  • Signing a five-year collaboration with Arthrex, Inc., under which ThermoGenesis, in consultation with Arthrex's on staff clinicians, has developed two line extensions of Res-Q®, specifically formulated to produce a proprietary composition of platelet rich plasma (PRP) and bone marrow concentrate. Arthrex has global exclusive distribution rights for this proprietary, private-labeled product. The Company expects to record initial revenues from this agreement in its fourth fiscal quarter.
  • Presenting data from Critical Limb Ischemia and long bone fracture clinical evaluations using concentrates prepared by the Res-Q that demonstrate initial positive outcomes.
  • Being selected by Canadian Blood Services to provide the BioArchive System for a new public cord blood bank that will commence operations a year from now.

Cytori Therapeutics (CYTX), with an MCAP of $135.0 million, announced its 2011 review on March 8th. The company announced Product revenues were $8.0 million in 2011 compared to $8.3 million in 2010. Gross profit on product sales was $4.1 million in 2011 compared to $4.3 million in 2010. Total operating expenses were $35.6 million in 2011, compared to $32.0 million in 2010. The company ended the year with $36.9 million in cash and equivalents along with an additional $2.3 million in accounts receivable.

The following pertinent 2011 stem cell research highlights were noted:

  • The company achieved important objectives towards validating Celution® technology in multiple large market indications (AND) clarified the U.S. cardiovascular pathway with FDA.
  • The Company reported positive long-term outcomes from two clinical trials, initiated a European pivotal heart attack trial, and in January 2012 received FDA approval to initiate a U.S. clinical trial for chronic myocardial ischemia (CMI).
  • Cytori's progress in 2011 has resulted in several visible milestones early in 2012, including approval to initiate our U.S. ATHENA trial, strengthening of our global patent position, and positive guidance by a UK reimbursement authority regarding breast reconstruction.

BioLife Solutions, Inc. (NASDAQ:BLFS), with an MCAP of $5.6 million, reported its 2011 review on March 26th. The company reported 2011 revenue of $2.8 million relative to $2.1 million for 2010. The company reported a net loss of $1.96 million ($0.03 per share) for 2011 relative to $1.98 million ($0.03 per share) for 2010.

The following pertinent 2011 stem cell research highlights were noted:

  • Revenue and customer base continued to grow with shipments of CryoStor®, HypoThermosol®, and BloodStor®, to dozens of new and to existing customers in strategic direct markets of regenerative medicine, biobanking, and drug discovery. The Company's estimated direct and indirect customer base now totals more than 400.
  • Revenue from distributors grew more than 150% over 2010 and was 20% of total revenue.
  • The Company executed a significant confidential multi-year contract manufacturing services agreement to perform aseptic media formulation, fill, and finish of several biopreservation solutions for a new multinational customer.

BioTime, Inc. (NYSEMKT:BTX), with an MCAP of $191.2 million, reported its 2011 review on March 14th. The company reported 2011 revenue of $4.4 million relative to $3.7 million for 2010. Net loss for the year was $16.5 million ($0.35 per share) relative to $11.2 million loss ($0.28 per share) for 2010. Cash and equivalents for year end 2011 were $22.2 million relative to $33.3 million for 2010.

The following pertinent 2011 stem cell research highlights were noted:

  • Successfully completed ISO 10993 biocompatibility studies for HyStem®-Rx. The results of these preclinical studies demonstrated the safety and biocompatibility of HyStem®-Rx. The first clinical application of HyStem®-Rx will be for use with autologous adipose cells to restore subcutaneous tissue lost as a result of injury, oncologic resection, or congenital defects.
  • Published in the peer-reviewed journal Stem Cell Research the complete genome sequence analysis of five clinical-grade human embryonic stem cell lines. "Evaluating the Genomic and Sequence Integrity of Human ES Cell Lines: Comparison to Normal Genomes" is the first such analysis of the entire genome of human embryonic stem cell lines and further establishes BioTime's lead in developing fully characterized cell lines intended for use in the manufacture of therapeutics.

BrainStorm Cell Therapeutics (OTCQB:BCLI), with an MCAP of $31.0 million, announced its 2011 review on March 29th. The company reported a loss for 2011 of $3.92 million ($0.03 per share) relative to $2.40 million ($0.03 per share) in 2010. The company noted that they have "financed our operations since inception primarily through private sales of our common stock and warrants and the issuance of convertible promissory notes. At December 31, 2011, we had $2,304,000 in total current assets and $1,135,000 in total current liabilities."

The following pertinent 2011 stem cell research highlights were noted:

  • In June 2011, we initiated a Phase I/II clinical study for ALS patients using our autologous NurOwn™ stem cell therapy, after receiving final approval from the Israel MOH.
  • In February 2011, the FDA granted Orphan Drug designation to our NurOwn™ autologous adult stem cell product candidate for the treatment of ALS. Orphan Drug status entitles us to seven years of marketing exclusivity for NurOwn™ upon regulatory approval.
  • As a result of limited cash resources and the desire to take a faster path to clinical trials, since the fourth quarter of 2008 we have focused all of our efforts on ALS, and are currently not allocating resources towards PD, MS or other neurodegenerative diseases. Other indications are currently being evaluated.

Author's Comments:

2011 was an exciting year for the stem cell biotechs culminating with the FDA s first approval of a stem cell therapy through New York Blood Center's allogeneic cord-blood product, Hemacord. Helping to legitimize the stem cell therapy approach, 2012 and beyond could witness other approvals and trial successes to further validate the stem cell approach for treating many conditions. Although the sector is still taking "baby steps" as it progresses through the laborious and expensive clinicals, the knowledge gained will never be lost and will continue building to levels allowing ever-increasing efficacy and safety profiles as the sector continues to mature. Success and failure with both lead to future success and help to further legitimize the field. Large pharmaceuticals, investors, the medical community and patients in need with be watching the sector's progression with great interest and hope as this exciting technology and its implications are more fully realized.

Source: Stem Cell Biotechs Report 2011 Year In Review: Part II