Henry McCusker's  Instablog

Net loss was $1.1 M or $0.07 per share

Net loss for Q3/13 was $1.1 M or $0.07 per share compared with $1.8 M or $0.11 per share in Q3/12.

Revenue was $3.2 M per share compared with $4.9 M in Q3/12. R&D expenses were $658 K compared to $959 K for Q3/12. G&A expenses were $1.5 M compared to $1.2 M in Q3/12. Total expense was $2.8 M, compared to a total expense of $4.3 M for Q3/12. Top line performance increased more than $700 K or 19% driven by several factors including sales increase of AutoXpress Platform disposables and manual bag sets, and disposables from products used to prepare stem cell concentrates from bone marrow. Growth was driven by several factors, including an increase in sales of AutoXpress(R) Platform (AXP) disposables and manual bag sets. KOOL benefited from increased disposable sales from products used to prepare stem cell concentrates from bone marrow, due to increased sales to its distributor, Celling Technologies.

• KOOL had a total of $7.5 million in cash, cash equivalents, and investments compared to $7.9 M in cash and cash equivalents at 12/31/12.

Q1/13 Highlights

• Added Crioestaminal, a leading cord blood stem cell bank in Portugal, as a customer for AXP System, replacing a competitor's product;
• Appointed Dan Bassey as CFO. Dan brings more than 20 years of finance and accounting experience, with strong expertise in operations, strategic planning and M&A.

The Bottom Line: KOOL struggles to break the $1.00 mark - last seen on 1/14/13. A "footprint" in China with a 5 year contract … could boost revenues <and other Asian countries>but by when? KOOL continues to better leverage its cost structure to increase core revenues year-over-year they reduced operating loss in Q1/13 by $500 K which excluded the gain on sales of assets and … their cash balance remained consistent.

Reduced net loss by $640 K through cost management strategies, despite $619 K in costs related to litigation and positioning initiatives. 22% of their $2.8 M in total operating expenses was non-core operating costs, including litigation related expenses and those incurred to support our longer term growth initiatives. In the conference call, Matt said - KOOL not infringe that there patents < the patent for the rescue system> were invalid and Harvest has requested more time to respond to KOOL counterclaim answers - the 1st bullet. Will this get thrown out?

My follow-on question is - how does KOOL maintain their software with their current abilities and capacities? Also the revenue regeneration is "not" theirs but the distributors - again issues of control and motivation. and for a 3rd bullet - is there … competitive trouble trouble brewing … with SynGen and their <KOOL's> former founder … concerning more superior harvesting capacity? See … @ syngeninc.com … who has been funded by Bay City Capital.

KOOL has completed a P1 and P1b study in CLI; the CLI P1 trial with the University of Naples was published last quarter. The data show that 1 year following administration of the cells that 10 of the 13 patients showed improve blood flow and as a whole, the cohorts blood flow doubled, which is compelling but - early. The P1b CLI study conducted with our other partner … TotipotentRX … in India treated 15 patients, which also compelling interim results. These were very sick patients, were specific or significant prior medical interventions had failed to achieve re-vascularization and each were within 24 hours of limb amputation. KOOL completed a P1 study of non-union fractures with its partner, TotipotentRX in US and India. This P1 study totaled 19 enrolled patients, of which 5 were last follow-up, each of whom had failed numerous prior surgical attempts at bone fusion. The study showed significant improvements in healing and pain scores as well as the 71% union rate within 18 weeks. Based on these results, we're planning a P2 study for non-union fractures in conjunction with our partner.

The 4th bullet … Why is KOOL in the "therapeutic" development business - a tremendous cash drain!!

KOOL closed UP +$0.03 to $on 5/13/12 on 65.5 K shares; was UP again +$0.05 to $0.95 on 5/14 with 32.4 K shares but, drifted DOWN to $0.91 on 5/15/15 on 22.6 K shares. A … HOLD based on revenue "pushes" otherwise KOOL will "drip" downward as 2013 "floats" on!

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

Malaysia, Philippines and South Africa

NeoStem experienced geographic expansion of intellectual property protection around its lead product candidate, AMR-001, with the notice of patent grant in Malaysia (MY-147516-A) and notice of recommendation for patent allowance in the Philippines (1-2008-501074). These patents are in the family of U.S. patent number 7,794,705 titled "Compositions and Methods of Vascular Injury Repair" and protect a chemotactic stem cell product enriched for CD34+ cells that treats injury from acute myocardial infarction ("AMI").

Additionally, NeoStem has been granted a second South African patent (ZA 2011/04059) titled "Infarct Area Perfusion-Improving Compositions and Methods of Vascular Injury Repair."

The Bottom Line: These incremental patents will bring AMR-001′s total worldwide patent coverage to nine patents. The Asian and African geographic expansion of Amorcyte's patent protection, also includes Japan, creates the potential to access markets where heart attack and cardiovascular disease are significant threats to public health.

NBS closed at $0.59 and should be UP as buys <4800>out-rank offers<700> pre the open - expect a penny or two UP today.

Addendum - NBA opened UP +$0.03 or +5.56% to $0.62.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

Net loss for of $9.4 million or $0.18 per share

Net loss for of $9.4 million or $0.18 per share compared to a net loss of $4.3 million or $0.17 per share for Q1/12.

Total revenues were $300 K compared to $2.7 million in Q1/12, reflecting a $2.4 million decrease in Pfizer contract revenues. The Pfizer-related contract revenues included the amortization of collaboration payments over an estimated performance period that ended in 6/12. Grant revenue remained relatively consistent for the periods presented, but may fluctuate from period to period based on the timing of grant-related activities and the award of new grants.

R&D expenses were $5.6 million for both Q1/13 and Q1/12, with clinical and preclinical development and personnel costs also remaining consistent. G&A expenses increased to $1.5 million compared to $1.3 million in Q1/12, due to increases in legal and professional fees. Net other income (expense) was $17 K, compared to expense of $800 K for Q1/12 was primarily related to milestone payments to former lenders that were concluded in 2012. The change in the fair value of warrant liabilities resulted in expense of $2.6 million, compared to income of $600 K in Q1/12, due to the re-pricing of warrants issued in 3/12 financing and increases in share pricing.

Net cash used in operating activities was $6.1 million, compared to $5.4 million in Q1/12 which was offset by $2 million in proceeds from equity sales <usage>pursuant to Aspire Capital Fund equity purchase agreement. Shares used in computing the net loss were 53.45 million versus 25.54 million in Q1/12.

• ATHX ended with $21.3 million in cash and cash equivalents, compared to $25.5 million at 12/31/12.

Q1/13 Highlights:

• Authorization from the U.K. Medicines and Healthcare products Regulatory Agency ("MHRA") authorizing the inclusion of UK stroke centers in ongoing P2 clinical study of MultiStem(R) cell therapy to treat ischemic stroke;
• Continued P2 clinical study with partner, Pfizer (PFE), involving administration of MultiStem cells to patients suffering from ulcerative colitis. Initial results from this double blind, placebo-controlled trial are expected in Q4/13;
• Published 2 articles in peer-reviewed scientific journals, Journal of Immunology and Circulation, demonstrating relevance of MultiStem for autoimmune disease, transplantation and vascular disease;
• Continued partnering discussions focused on 5HT2c agonist program for potential treatment of obesity and other conditions such as schizophrenia, and on certain cell therapy programs.

The Bottom Line: ATHX's focus remains MultiStem for ulcerative colitis with PFE and MultiStem for ischemic stroke.

Research and support commitments under the PFE-RTI collaborations are essentially complete - absent any new business collaboration, ATHX contract revenue will be reduced as we saw in Q1/13.

ATHX has 2 ongoing MultiStem P2b clinical trials, a study in ulcerative colitis in collaboration with PFE and an ischemic stroke study. ATHX have several other programs, which we could move forward in the mid to late stage clinical development, including the proposed P2 & 3 study evaluating MultiStem to prevent GvHD currently being reviewed by the FDA and also a potential P2 study in the cardiovascular area - however, ATHX is not planning moving studies ahead until they secure additional proceeds.

What did I hear new - nothing - radio silence - same message working on all fronts in multiple and proposed efforts!

ATHX closed at $2.12 after running the gamut in the May period and mid-April. ATHX was DOWN -5.7% on 27 K shares in yesterday's after-market and today's indication is DOWN in the range $1.92 to $2.06. Earnings usually drop the shares post the vent until they work their way through the trader's sandbox

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.