Cell Therapy Industry HiLites 2009-01-09

Ok so there was no deluge of cell therapy news this week despite my fears (hopes?). The only flood was the river (nee creek) behind my house. Wow, water can rise fast! Anyway...that's not cell therapy, THIS is cell therapy:

Osiris Therapeutics (NASDAQ:OSIR) received a $5 million milestone payment for reaching the first production threshold of the Osteocel supply agreement with NuVasive. In July of 2008, Osiris announced the sale of the Osteocel business to NuVasive for an initial payment of $35 million, followed by up to $50 million in additional milestones. Osiris expects to achieve the remaining $45 million in milestone payments from NuVasive, including $17.5 million for further delivery of product, $12.5 million upon transfer of certain manufacturing assets, and a $15 million payment upon NuVasive’s achievement of $35 million in cumulative Osteocel sales.

After announcing last week that they had raised $1M of an anticipated $5M round of financing, International Stem Cell Corporation (OTCBB:ISCO) issued a press release to 'discuss' the recent funding. The additional funds are to be raised in four $1M tranches in February, March, June and September.

They need the additional funds to meet their goals for 2009, namely
(1) eliminating $1 million of outstanding secured debt;
(2) supporting first quarter pre-clinical trials; and
(3) providing marketing and expansion capital to position the Company`s "Lifeline" subsidiary - which makes and sells specialty cells and growth media - to the point where it will be generating profit (within two years) that they can then plow back into the company's clinical research.

I'm no corporate finance expert but this is what I read from the SEC filing behind the press releases. Andrei Semechkin, Rouslan Semechkin, and X-Master, Inc were the investors putting up the $1M to-date. By way of a "material and essential inducement for the Investors to enter into the Preferred Stock Purchase Agreement, the Company agreed to employ Rouslan Semechkin and Andrei Semechkin in accordance with the terms" of the employment agreements attached to the stock purchase agreement. Andrei is going to be paid at least $180,000 per year for the next 5 years as the company's Chief Business Officer and Rouslan is also on salary.

So, provided ISCO stays around, Andrei and Rouslan will get their $1M back over 5 years in addition to whatever benefits they may glean from their shares. This certainly seems like a nice, low - albeit not entirely without - risk arrangement. On the other hand, this could be seen as them putting their own money in first where they are asking others to follow or they may buck up more money on the subsequent tranches. However this plays out, it is another testament to the fact that in biotech, survivability is so-oft closely if not directly tied to financing creativity!

You likely won't find a press release about this one but J&J is quietly shuttering at least two of their cell therapy programs. Their autologous HIV cell therapy program and their Treg program are both on the out-licensing block after corporate decided to shut down the programs - the former after reportedly 'good' phase II data and the latter even before it went clinical. J&J is not announcing what's behind the decisions though unofficial reports are that it is not a lack of belief in cell therapies overall. Speculation is that it is primarily HQ needing to conserve spending on longer-term programs. Whatever is behind the decisions, it's a little disappointing because for a couple of years now J&J has been quietly been the largest cell therapy company in the world if one added up all their cell therapy internal programs and external investments. They may well still deserve this title but they're a little smaller this month then they were before.

So...since it was a little slow on the industry front, I'll finish with three non-business related items I found interesting this week:

WIRED has published its much-read list of top scientific breakthroughs of the past year and not only do life sciences figure prominently in the top-10 but two of them are cell therapy related. On the list: A new approach to reprogramming stem cells to avoid a tendency to become cancerous; using a bone marrow transplant from an HIV-resistant donor in Germany to eradicate the virus, pointing to gene editing as a possible cure; and using a patient's stem cells to grow a new trachea. The new trachea was number two on the hit parade and earned kudos as the greatest single breakthrough in life sciences.

Adding fuel to the 'cancer stem cell' debate, Canadian researcher Mick Bhatia, and his team, have published a letter abstract in Nature Biotechnology, on a series of tests they claim can distinguish between cancer stem cells and the good kind. Thus enabling, inter alia, the better targeting of cancer stem cells.

Cell Transplantation has become an "open access" journal from the 1st January 2009, starting with volume 18, making it available on the World Wide Web without subscription to researchers and clinicians as well the public and members of the media.

Finally, Dawn Driscoll (DCi Biotech) and I are putting on a 1/2-day course entitled Commercial Considerations for Cell-Based Therapies Feb. 24 at the Moscone Center in San Francisco immediately prior to CHI's Stem Cell Congress (part of their Molecular Medicine Tri-Conference). Let me know if you're interested.

That's cell therapy the way I saw it in this first whole week of 2009...